DEVICE AND METHOD FOR SUTURING INTRACARDIAC DEFECTS

• US 20090048615A1
• Filed: 10/23/2008
• Published: 02/19/2009
• Est. Priority Date: 09/26/2003
• Status: Active Grant

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: McIntosh, Scott A.
• Granted Patent: US 8,361,088 B2
• Time in Patent Office: Days
• 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

In accordance with the present invention there is provided a suturing device. The suturing device includes a length of suture that will be delivered to the site of the PFO and placed through the tissue adjacent the opening to close the PFO. As described in greater detail below, the suture is advanced through the tissue surrounding the opening by a pair of needles that penetrate the tissue adjacent to the opening. A knot is then loosely tied with the length of suture and advanced to the site of the PFO. The tails of the suture extending from the knot are then cut and removed. It is also contemplated that a pre-formed or pre-tied knot may be disposed on the device, wherein after deployment of the suture through the tissue adjacent to the PFO and removal of the device a loop of suture having a pre-tied knot will remain, wherein the pre-tied knot may then be tightened to close the PFO. Further still it is contemplated that other means may be utilized to retain the sutures. For example, it is contemplated that a suture clip or other clip like device may be utilized to retain the suture in a position such that the PFO is closed.

Claims

1-18. -18. (canceled)

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

providing a suturing device including 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;

a foot housing extending from the distal end of the shaft, the foot housing defining a pre-formed curve portion formed to carry a pivotable first foot, the first foot being operatively connected to a foot actuation wire, the foot actuation wire being connected to the foot actuation handle;

at least one needle extending from the needle actuation handle and through the shaft;

a length of suture having two ends; and

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

advancing the suturing device through the inferior vena cava, right atrium, and patent foramen ovale such that the foot is positioned in the left atrium;

deploying the first foot to a deployed position;

orienting the suture 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 at least one needle through tissue and further into a first needle receptacle; and

advancing at least one end of the length of suture through the tissue to suture the PFO.

20. The method according to claim 19, wherein:

the foot housing further carrying a pivotable second foot, the second foot being operatively connected to the foot actuation wire;

said method further including;

prior to the advancing at least one end of the length of suture, deploying the second foot to a deployed position; and

advancing a second needle through tissue and further into a second needle receptacle.

21. The method according to claim 20, further including:

independently deploying the first foot and the second foot to the respective deployed position.

22. The method according to claim 20, wherein:

said deploying the first foot is at an angle, relative to the longitudinal axis of the foot housing, different from that of the other foot.

23. The method according to claim 20, further including:

simultaneously deploying the first foot and the second foot to the respective deployed position, wherein the first foot and second foot are substantially aligned along a common longitudinal axis.

24. The method according to claim 20, wherein:

the advancing of one of the one needle and the second needle is performed in the proximal direction, and the other of the second needle and the one needle is performed in the distal direction.

25. The method according to claim 20, wherein:

the first and second needles each include a hollow portion housing a respective, detachable suture toggle therein, one toggle being disposed on one end of the length of suture and the other toggle being slidable disposed along the length of the suture, said method further including;

after the advancing of the needles through the respective tissue, detaching tile one suture toggle from the respective needle, and sliding the other suture toggle along the suture to tension the other suture toggle against the tissue to suture the PFO.

26. The method according to claim 19, wherein:

said suture device includes a locking device configured to cooperate with the length of suture for locking thereof, and

said advancing the at least one end of the length of suture further including engaging the locking element to lockably suture the PFO.

27. The method according to claim 26, wherein:

said locking device includes a locking element one end of the length of suture, and a plurality of beads along a length of the suture, and

said engaging the locking element includes passing one or more of the plurality of beads through the locking element for locking engagement therewith.

28. The method according to claim 26, wherein:

said locking device includes a seal member defining at least one suture aperture sized for sliding receipt of the suture therethrough, said seal member being sized and dimensioned to extend at least partially over and against the proximal side of the sutured PFO;

said engaging the locking element including;

passing the one end and an opposite other end of the length of suture through the at least one suture aperture;

tensioning and locking the seal member along the drawn suture, and against the proximal side of the sutured PFO.

29. The method according to claim 20, wherein:

said suturing device includes a flexible filament disposed along the length of the first foot and the second foot, and

said advancing the at least one needle of the suturing device through the one of the tissue further causing a first end of the flexible filament to couple to the one end of—

the length of suture, and

said advancing a second needle of the suturing device through the tissue further causing the second end of the flexible filament to releasably coupled to the second needle.

30. The method according to claim 29, further including:

retracting the second needle from the second needle receptacle of the deployed second foot, and the tissue, and causing the second end of the flexible filament, coupled to the second needle, to be drawn the tissue.

31. The method according to claim 30, wherein:

said advancing at least one end of the length of suture through the tissue is further performed by drawing the flexible filament, coupled to the one end of the length of suture, through the tissue until the one end of the length of suture, coupled to the first end of the flexible filament, is also drawn there through.

42. The method according to claim 19, wherein:

said deploying the first foot includes deploying the first foot about a pivotal axis oriented proximate to and distal from a nadir of the pre-formed curved portion of the foot housing.

43. The method according to claim 20, wherein:

the deploying the of the first foot and the second foot are such that a length of the deployed first foot from a distal end thereof to the foot housing is longer than that of the second foot.

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

providing a suturing device including a flexible shaft that supports a distal foot housing defining a pre-formed curve portion having bight, and having a pivotal first foot selectively deployable from a low profile configuration to a deployed configuration;

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

deploying the first foot to a deployed position such that the first foot is oriented at a selectable acute angle from a longitudinal axis of the foot housing 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—

a Secundum tissue;

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

advancing at least one needle of the suturing device through the one of the Primum tissue and Secundum tissue, and into receptive association with the deployed first foot, said 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 to suture the PFO.

33. The method according to claim 32, wherein:

said foot housing further includes a pivotal second foot selectively deployable from a low profile configuration to a deployed configuration, said second foot being generally positioned on an opposite side of the foot housing relative to the first foot, said method further including;

deploying a second foot to a deployed position such that the second foot is oriented at an acute angle from a longitudinal axis the foot housing.

34. The method according to claim 33, further including:

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

said method further includes 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 second foot.

35. The method according to claim 34, wherein:

said suturing device includes a flexible filament disposed along the length of the first foot and the second foot, and wherein

said advancing at least one needle of the suturing device through the one of the Primum tissue and Secundum tissue further causing a first end of the flexible filament to couple to the one end of the length of suture, and

said advancing a second needle of the suturing device through the other of the Secundum tissue and Primum tissue further causing the second end of the flexible filament to releasably coupled to the second needle.

36. The method according to claim 35, further including:

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

37. The method according to claim 36, wherein:

said drawing the one end of the length of suture through the tissue is further performed by drawing the flexible filament, coupled to the one end of the length of suture, through the other of the Secundum tissue and Primum tissue until the one end of the length of suture, coupled to the first end of the flexible filament, is also drawn there through.

38. The method according to claim 32, wherein:

an end of the first needle having a distal end carrying a detachable tip, the detachable tip connected to the one end of a length of suture; and

said method further including detaching the detachable tip from the first needle.

39. The method according to claim 32, wherein:

said suture device includes a locking device configured to cooperate with the length of suture for locking thereof, and

said drawing one end of the length of suture further including engaging the locking element to lockably suture the PFO.

40. The method according to claim 39, wherein:

said locking device includes a locking element one end of the length of suture, and a plurality of beads along a length of the suture, and

said engaging the locking element includes passing one or more of the plurality of beads through the locking element for locking engagement therewith.

41. The method according to claim 39, wherein:

said locking device includes a seal member defining at least one suture aperture sized for sliding receipt of the suture therethrough, said seal member being sized and dimensioned to extend at least partially over and against a proximal side of the sutured PFO;

said engaging the locking element including;

passing the one end and an opposite other end of the length of suture through the at least one suture aperture;

tensioning and locking the seal member along the drawn suture, and against the proximal side of the sutured PFO.

44. The method according to claim 32, wherein:

said deploying the first foot includes deploying the first foot about a pivotal axis oriented proximate to and distal from a nadir of the pre-formed curved portion of the foot housing.

45. The method according to claim 34, wherein:

said positioning the deployed first foot includes orienting the first foot toward the Secundum tissue such that the distal end of the Secundum tissue is received in the bight portion of the foot housing, and

the deploying the of the first foot and the second foot are such that a length of the deployed first foot from a distal end thereof to the foot housing is longer than that of the second foot.

46. The method according to claim 32, wherein:

said selectable acute angle is less than about 80 Deg.

47. The method according to claim 32, wherein:

said selectable acute angle is less than about 51 Deg.