Methods and apparatus to achieve a closure of a layered tissue defect
Methods for treating anatomic tissue defects such as a patent foramen ovale generally involve positioning a distal end of a catheter device at the site of the defect, exposing a housing and energy transmission member from the distal end of the catheter, engaging the housing with tissues at the site of the defect, applying suction or other approximating tool to the tissue via the housing to bring the tissue together, and applying energy to the tissue with the energy transmission member or to deliver a clip or fixation device to substantially close the defect. Apparatus generally include a catheter body, a housing extending from a distal end of the catheter body for engaging tissue at the site of the defect, and further adapted to house a fusing or fixation device such as an energy transmission member adjacent a distal end of the housing, or a clip or fixation delivery element.
1 . An apparatus for positioning a closure device, the apparatus comprising:
an elongate member having a proximal end and a distal end; and
a guiding member on a distal portion of the elongate member, wherein the guiding member is adapted to indicate sizing and orientation of a layered tissue defect.
2 . An apparatus as in claim 1 , wherein the guiding member is further adapted to indicate depth of the layered tissue defect.
3 . An apparatus as in claim 1 , further comprising a closure device adjacent to a distal portion of the elongate member.
4 . An apparatus as in claim 3 , wherein the guiding member is adapted to facilitate positioning of the closure device into apposition with the layered tissue defect so that the closure device may effectively seal the layered tissue defect.
5 . An apparatus as in claim 4 , wherein the closure device is slidably movable over the guiding member.
6 . An apparatus as in claim 1 , wherein the guiding member comprises an expandable member.
7 . An apparatus as in claim 6 , wherein the expandable member is a balloon.
8 . An apparatus as in claim 7 , wherein the expandable member further comprises radiopaque markers.
9 . An apparatus as in claim 7 , wherein the balloon releases contrast media into the layered tissue defect facilitating estimation of defect anatomy and dimensions.
10 . An apparatus as in claim 1 , wherein the guiding member comprises a tapered set of elongated members.
11 . An apparatus as in claim 1 , wherein the guiding member comprises a plurality of arms.
12 . An apparatus as in claim 11 , wherein the arms are moveable arms.
13 . An apparatus as in claim 1 , wherein the guiding member comprises a plurality of wire-like whiskers.
14 . An apparatus as in claim 1 , wherein the guiding member comprises a looped wire.
15 . An apparatus as in claim 14 , wherein the looped wire has a variable stiffness along its perimeter.
16 . An apparatus as in claim 1 , wherein the guiding member is slidably disposed in a distal portion of the elongate member.
17 . An apparatus as in claim 16 , wherein the guiding member forms a smooth surface with the elongate member when the guiding member is retracted into the elongate member.
18 . An apparatus as in claim 1 , further comprising a sheath, wherein the guiding member is slidably retractable into the sheath.
19 . An apparatus as in claim 1 , further comprising radiopaque markers disposed on the guiding member.
20 . An apparatus as in claim 1 , further comprising a guidewire lumen having an exit port near the distal end of the elongate member.
21 . An apparatus as in claim 1 , wherein the guiding member comprises a plurality of extensible rails.
22 . An apparatus as in claim 1 , wherein the guiding member comprises an extended nose-like portion adjacent to the distal end of the elongate member.
23 . An apparatus as in claim 1 , wherein the guiding member comprises one or more compound bends and wherein the bends are adapted to position the closure device.
24 . An apparatus as in claim 1 , wherein the layered tissue defect is selected from the group consisting of patent foramen ovale, atrial septal defect, ventricular septal defect, patent ductus arteriosis and left atrial appendage.
25 . An apparatus as in claim 3 , wherein the guiding member is adapted to position the closure device while the guiding member is inserted into the tunnel of a patent foramen ovale.
26 . An apparatus as in claim 3 , wherein the guiding member is adapted to position the closure device through the septum of a human heart.
27 . A system for positioning a closure device, the system comprising:
an elongate member having a proximal end and a distal end; and
a guiding member on a distal portion of the elongate member, wherein the guiding member is adapted to indicate sizing and orientation of a layered tissue defect.
28 . A system as in claim 27 , wherein the guiding member is further adapted to indicate depth of the layered tissue defect.
29 . A system as in claim 27 , further comprising a closure device adjacent to a distal portion of the elongate member.
30 . A system as in claim 29 , wherein the guiding member is adapted to facilitate positioning of the closure device into apposition with the layered tissue defect so that the closure device may effectively seal the layered tissue defect.
31 . A system as in claim 30 , wherein the closure device is slidably movable over the guiding member.
32 . A system as in claim 27 , wherein the guiding member comprises an expandable member.
33 . A system as in claim 32 , wherein the expandable member is a balloon.
34 . A system as in claim 33 , wherein the expandable member further comprises radiopaque markers.
35 . A system as in claim 33 , wherein the balloon releases contrast media into the layered tissue defect facilitating estimation of defect anatomy and dimensions.
36 . A system as in claim 27 , wherein the guiding member comprises a tapered set of elongated members.
37 . A system as in claim 27 , wherein the guiding member comprises a plurality of arms.
38 . A system as in claim 37 , wherein the arms are moveable arms.
39 . A system as in claim 27 , wherein the guiding member comprises a plurality of wire-like whiskers.
40 . A system as in claim 27 , wherein the guiding member comprises a looped wire.
41 . A system as in claim 40 , looped wire has a variable stiffness along its perimeter.
42 . A system as in claim 27 , wherein the guiding member is slidably disposed in a distal portion of the elongate member.
43 . A system as in claim 42 , wherein the guiding member forms a smooth surface with the elongate member when the guiding member is retracted into the elongate member.
44 . A system as in claim 27 , further comprising a sheath, wherein the guiding member is slidably retractable into the sheath.
45 . A system as in claim 27 , further comprising radiopaque markers disposed on the guiding member.
46 . A system as in claim 27 , further comprising a guidewire lumen having an exit port near the distal end of the elongate member.
47 . A system as in claim 27 , wherein the guiding member comprises a plurality of extensible rails.
48 . A system as in claim 27 , wherein the guiding member comprises an extended nose-like portion adjacent to the distal end of the elongate member.
49 . A system as in claim 27 , wherein the guiding member comprises one or more compound bends and wherein the bends are adapted to position the closure device.
50 . A system as in claim 27 , wherein the layered tissue defect is selected from the group consisting of patent foramen ovale, atrial septal defect, ventricular septal defect, patent ductus arteriosis and left atrial appendage.
51 . A system as in claim 29 , wherein the guiding member is adapted to position the closure device while the guiding member is inserted into the tunnel of a patent foramen ovale.
52 . A system as in claim 29 , wherein the guiding member is adapted to position the closure device through the septum of a human heart.
53 . A system as in claim 27 , further comprising a closure device adapted to treat a layered tissue defect, wherein the closure device is selected based on the sizing indicated by the guiding member.
54 . A method for fusing layered tissue defects, the method comprising:
advancing a treatment apparatus to a first treatment site having a layered tissue defect;
positioning the treatment apparatus so that the apparatus may be placed into apposition with the layered tissue defect and wherein the treatment apparatus may effectively seal the layered tissue defect; and
treating the layered tissue structure with the treatment apparatus so that the layered tissue defect is effectively sealed.
55 . A method as in claim 54 , wherein positioning comprises inserting a guiding member into the layered tissue defect.
56 . A method as in claim 54 , wherein positioning comprises inserting a guiding member into the tunnel of a patent foramen ovale.
57 . A method as in claim 54 , wherein positioning comprises expanding an expandable member.
58 . A method as in claim 54 , wherein positioning comprises inflating a balloon.
59 . A method as in claim 54 , wherein positioning comprises expanding a plurality of arms.
60 . A method as in claim 54 , wherein the treatment apparatus comprises:
an elongate member having a proximal end and a distal end;
a guiding member on a distal portion of the elongate member, wherein the guiding member is adapted to indicate sizing and orientation of the layered tissue defect.
61 . A method as in claim 60 , wherein the guiding member is further adapted to indicate length of the layered tissue defect.
62 . A method as in claim 60 , further comprising a closure device adjacent to a distal portion of the elongate member.
63 . A method as in claim 62 , wherein the guiding member is adapted to facilitate positioning of the closure device into apposition with the layered tissue defect so that the closure device may effectively seal the layered tissue defect.
64 . A method as in claim 63 , wherein the closure device is slidably movable over the guiding member.
65 . A method as in claim 60 , wherein the guiding member comprises an expandable member.
66 . A method as in claim 65 , wherein the expandable member is a balloon.
67 . A method as in claim 66 , wherein the expandable member further comprises radiopaque markers.
68 . A method as in claim 66 , wherein the balloon releases contrast media into the layered tissue defect facilitating estimation of defect anatomy and dimensions.
69 . A method as in claim 60 , wherein the guiding member comprises a tapered set of elongated members.
70 . A method as in claim 60 , wherein the guiding member comprises a plurality of arms.
71 . A method as in claim 70 , wherein the arms are moveable arms.
72 . A method as in claim 60 , wherein the guiding member comprises a plurality of wire-like whiskers.
73 . A method as in claim 60 , wherein the guiding member comprises a looped wire.
74 . A method as in claim 73 , wherein the looped wire has a variable stiffness along its perimeter.
75 . A method as in claim 60 , wherein the guiding member is slidably disposed in a distal portion of the elongate member.
76 . A method as in claim 75 , wherein the guiding member forms a smooth surface with the elongate member when the guiding member is retracted into the elongate member.
77 . A method as in claim 60 , wherein the treatment apparatus further comprises a sheath, and wherein the guiding member is slidably retractable into the sheath.
78 . A method as in claim 60 , wherein the treatment apparatus further comprises radiopaque markers disposed on the guiding member.
79 . A method as in claim 60 , wherein the treatment apparatus further comprises a guidewire lumen having an exit port near the distal end of the elongate member.
80 . A method as in claim 60 , wherein the guiding member comprises a plurality of extensible rails.
81 . A method as in claim 60 , wherein the guiding member comprises an extended nose-like portion adjacent to the distal end of the elongate member.
82 . A method as in claim 60 , wherein the guiding member comprises one or more compound bends and wherein the bends are adapted to position the closure device.
83 . A method as in claim 60 , wherein the layered tissue defect is selected from the group consisting of patent foramen ovale, atrial septal defect, ventricular septal defect, patent ductus arteriosis and left atrial appendage.
84 . A method as in claim 62 , wherein the guiding member is adapted to position the closure device while the guiding member is inserted into the tunnel of a patent foramen ovale.
85 . A method as in claim 62 , wherein the guiding member is adapted to position the closure device through the septum of a human heart.
86 . A method as in claim 60 , further comprising selecting a treatment apparatus for treating a layered tissue defect, based on the sizing indicated by the guiding member.
87 . A method as in claim 54 , wherein positioning the treatment apparatus comprises expanding at least one expandable member against the layered tissue defect to indicate sizing of the defect.
88 . A method as in claim 87 , wherein the at least one expandable member is a balloon.
89 . A method as in claim 87 , wherein positioning the treatment apparatus comprises guiding the treatment apparatus with the at least one expandable member, so that the treatment apparatus is in apposition with the layered tissue defect.
90 . A method as in claim 89 , further comprising retracting the at least one expandable member from the layered tissue defect.
91 . A method as in claim 54 , wherein positioning the treatment apparatus comprises advancing one or more flexible members against the layered tissue defect to indicate sizing of the defect.
92 . A method as in claim 91 , wherein flexible members are wire-like.
93 . A method as in claim 91 , wherein positioning the treatment apparatus comprises guiding the treatment apparatus with the one or more flexible members, so that the treatment apparatus is in apposition with the layered tissue defect.
94 . A method as in claim 93 , further comprising retracting the one or more flexible members from the layered tissue defect.