Systems and Methods for Treating Septal Defects
A system for treating a septal defect having an implantable treatment apparatus and devices for delivering the implantable treatment apparatus and methods for treating a septal defect are provided. The implantable treatment apparatus is preferably implantable through a septal wall or portion thereof. The treatment system can include a flexible elongate body member, a delivery device configured to deliver the implantable apparatus, a stabilization device configured to stabilize the body member and a positioning device configured to position the delivery device in a desired location.
1 . A treatment system, comprising:
a first flexible elongate member; and
a second flexible elongate member having a distal end adjustably coupled with the first elongate member, wherein the orientation of the distal end is adjustable from a first orientation to a second orientation upon movement of the second elongate member with respect to the first elongate member.
2 . The treatment system of claim 1 , wherein the distal end is rotatably coupled with the first elongate member.
3 . The treatment system of claim 1 , wherein the distal end is flexibly coupled with the first elongate member.
4 . The treatment system of claim 1 , wherein the second elongate member is configured to deliver at least one implantable treatment device.
5 . The treatment system of claim 1 , wherein the second elongate member has an inner lumen with an open distal end configured to slidably receive a needle member.
6 . The treatment system of claim 5 , wherein the needle member has an inner lumen with an open, substantially sharp, distal end.
7 . The treatment system of claim 6 , wherein the inner lumen of the needle member is configured to slidably receive an inner elongate member having a distal end configured to contact an implantable treatment device.
8 . The treatment system of claim 7 , wherein the inner member is configured to push the implantable treatment device in a distal direction.
9 . The treatment system of claim 8 , wherein the inner lumen of the needle member is configured to house the implantable treatment device.
10 . The treatment system of claim 7 , wherein the inner member is configured to pull the implantable treatment device in a proximal direction.
11 . The treatment system of claim 10 , wherein the needle member is configured to store the implantable treatment device in a location at least partially external to the inner lumen of the needle member.
12 . The treatment system of claim 7 , wherein the distal end of the inner member has a contoured surface configured to contact the implantable treatment device.
13 . The treatment system of claim 7 , wherein a portion of the inner member proximal to the distal end of the inner member has a smaller width than a width of the distal end of the inner member.
14 . The treatment system of claim 5 , wherein the needle member comprises at least one aperture configured to provide flexibility.
15 . The treatment system of claim 5 , wherein the needle member comprises a pressure sensor.
16 . The treatment system of claim 1 , wherein the first elongate member has a first longitudinal axis and the second elongate member has a second longitudinal axis at the distal end of the second elongate member, the first and second longitudinal axes being substantially parallel when the distal end of the second elongate member is in the first orientation and transverse when the distal end of the second elongate member is in the second orientation.
17 . The treatment system of claim 1 , wherein the second elongate member is configured for movement with the vasculature of a patient when the distal end of the second elongate member is in the first orientation and for delivery of an implantable treatment device to a septal wall of the patient when the distal end of the second elongate member is in the second orientation.
18 . The treatment system of claim 17 , wherein the distal end of the second elongate member is substantially normal to a surface of the septal wall in the second orientation.
19 . The treatment system of claim 1 , wherein the distal end of the second elongate member is adjustable from the first orientation to the second orientation upon advancement of the second elongate member in a distal direction with respect to the first elongate member.
20 . The treatment system of claim 19 , wherein a portion of the second elongate member is configured to extend outwards from the first elongate member when the distal end of the second elongate member is in the second orientation.
21 . The treatment system of claim 20 , wherein the first elongate member has an inner lumen with an open distal end configured to slidably receive the second elongate member, the portion of the second elongate member configured to extend outwards being located outside of the inner lumen of the first elongate member.
22 . The treatment system of claim 1 , wherein the second elongate member comprises a braided sheath.
23 . The treatment system of claim 22 , wherein the braided sheath is a polymeric braided sheath.
24 . The treatment system of claim 22 , wherein the braided sheath is a metallic braided sheath.
25 . The treatment system of claim 1 , wherein the second elongate member comprises a coating.
26 . The treatment system of claim 1 , wherein the first elongate member comprises a coating.
27 . The treatment system of claim 1 , further comprising a tissue engagement device.
28 . The treatment system of claim 27 , wherein the tissue engagement device comprises an arm member coupled between the first elongate member and the distal end of the second elongate member.
29 . The treatment system of claim 28 , wherein the tissue engagement device further comprises:
a first hinge configured to rotatably couple the arm member with the first elongate member; and
a second hinge configured to rotatably couple the arm member with the distal end of the second elongate member.
30 . The treatment system of claim 28 , wherein the arm member is configured to pivot to engage tissue.
31 . The treatment system of claim 30 , wherein the arm member is configured to grasp tissue when the distal end of the second elongate member is in the second orientation.
32 . The treatment system of claim 31 , wherein the arm member is configured to clamp tissue between the arm member and one of the first elongate member or a third elongate member in a substantially fixed position with respect to the arm member.
33 . The treatment system of claim 30 , wherein the arm member has a surface configured to grasp a limbus of a septal wall of a patient.
34 . The treatment system of claim 28 , wherein the arm member is elastomeric.
35 . The treatment system of claim 28 , wherein the arm member is superelastic.
36 . The treatment system of claim 28 , wherein the arm member is configured to steer the distal end of the second elongate member.
37 . The treatment system of claim 36 , wherein the arm member comprises two wires movable with respect to each other and controllable by a user to steer the distal end of the second elongate member.
38 . The treatment system of claim 28 , wherein the arm member is biased to a position adjacent to a longitudinal axis of the first elongate member.
39 . The treatment system of claim 28 , wherein the arm member is configured to position the distal end of the second elongate member in a desired location on a septal wall of a patient.
40 . The treatment system of claim 39 , wherein the arm member has an adjustable length.
41 . The treatment system of claim 1 , further comprising a third elongate member configured to stabilize the position of at least one of the first elongate member and the second elongate member.
42 . A treatment system for treating a septal defect, comprising:
an implantable treatment device;
a flexible elongate delivery device having a first longitudinal axis and configured to deliver the implantable treatment device; and
an elongate body member having a second longitudinal axis and configured for insertion within the vasculature of a patient, the body member configured to slidably receive the delivery device, wherein the delivery device is configured to deliver the implantable treatment device along the first longitudinal axis when different than the second longitudinal axis.
43 . The treatment system of claim 42 , wherein the implantable treatment device is coiled.
44 . The treatment system of claim 42 , further comprising a stabilization device insertable within an opening in a septal wall and configured to stabilize the delivery device.
45 . The treatment system of claim 44 , wherein the body member has an inner lumen configured to slidably receive the delivery device and stabilization device.
46 . The treatment system of claim 44 , wherein a positioning device is integrated with the stabilization device.
47 . The treatment system of claim 46 , wherein the positioning device is a flexible positioning member configured to extend outwards from the stabilization device.
48 . The treatment system of claim 46 , wherein the body member has a first inner lumen configured to slidably receive the delivery device and a second inner lumen configured to slidable receive the stabilization device.
49 . The treatment system of claim 46 , wherein the stabilization device is configured to fixably couple with the delivery device such that rotation of the delivery device about the stabilization device is prevented.
50 . The treatment system of claim 44 , wherein the stabilization device is configured to fixably couple with the delivery device such that rotation of the delivery device about the stabilization device is prevented.
51 . The treatment system of claim 42 , wherein the delivery device further comprises a grasping device coupled between the delivery device and the body member.
52 . The treatment system of claim 42 , further comprising a positioning device insertable within a patent foramen ovate tunnel.
53 . The treatment system of claim 52 , wherein the positioning device is integrated with the body member.
54 . The treatment system of claim 53 , wherein the positioning device is a flexible positioning member.
55 . The treatment system of claim 54 , wherein the body member has an inner lumen configured to slidably receive the flexible positioning member, the inner lumen having a distal end configured to abut the distal end of the flexible positioning member and an open portion located proximal to the distal end of the lumen, wherein the flexible positioning member is configured to extend from the open portion upon advancement of the flexible positioning member distally against the distal end of the inner lumen.
56 . The treatment system of claim 53 , wherein the positioning device comprises a first and a second flexible positioning member and the body member is insertable within a patent foramen ovale tunnel, the first and second flexible positioning members being configured to position the body member within the tunnel.
57 . The treatment system of claim 56 , wherein the first and second flexible positioning members are configured to center the body member within the tunnel.
58 . The treatment system of claim 53 , wherein the body member has a first inner lumen configured to slidably receive the delivery device.
59 . The treatment system of claim 58 , further comprising a stabilization device insertable within an opening in a septal wall and configured to stabilize the delivery device, wherein the body member has a second inner lumen configured to slidably receive the stabilization device.
60 . The treatment system of claim 59 , further comprising a guidewire, wherein the second inner lumen is configured to slidably receive the guidewire.
61 . The treatment system of claim 58 , wherein the body member has a second inner lumen configured to slidably receive a guidewire.
62 . The treatment system of claim 53 , wherein the body member has a distal end with an atraumatic tip located thereon and the body member has an inner lumen configured to slidably receive the delivery device.