WO2007030433B1 - Removable intracardiac rf device - Google Patents
Removable intracardiac rf deviceInfo
- Publication number
- WO2007030433B1 WO2007030433B1 PCT/US2006/034504 US2006034504W WO2007030433B1 WO 2007030433 B1 WO2007030433 B1 WO 2007030433B1 US 2006034504 W US2006034504 W US 2006034504W WO 2007030433 B1 WO2007030433 B1 WO 2007030433B1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- energy
- elongated member
- pfo
- delivery element
- energy delivery
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—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
- A61B2017/00575—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 for closure at remote site, e.g. closing atrial septum defects
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—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
- A61B2017/00575—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 for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00592—Elastic or resilient implements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—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
- A61B2017/00575—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 for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
- A61B2018/00351—Heart
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B2018/1405—Electrodes having a specific shape
- A61B2018/1435—Spiral
Abstract
The present invention provides systems and methods for occluding or closing a patent foramen ovale of a patient (PFO). The invention includes a catheter carrying an energy delivery element. The catheter introduces the energy delivery element into the patent foramen ovale of a patient's heart. Once appropriately positioned, the energy delivery element applies energy, such as radiofrequency energy, to the tissues surrounding the patent foramen ovale. The application of energy causes the tissues to join together, occluding the patent foramen ovale. The energy delivery element may be removable or permanently implanted in the patent foramen ovale.
Claims
AMENDED CLAIMS received by the International Bureau on 21 June 2007 (21.06.07)
1 - A removable device for occluding a patent foramen ovale (PFO) comprising: a sheath having a proximal end and a distal end and comprising a lumen; an elongated member comprising a proximal end and distal end and axially disposed in the lumen of said sheath, at least one of said sheath and said elongated member axially moveable relative to the other; and an energy delivery element operatively joined to an energy source, said energy delivery element comprising at least one coil having a lumen, said elongated member axiaϊly disposed within die lumen of said coil, said at least one coil having a proximal end and a distal end, the distal end of the elongated member being connected to the distal end of said at least one coil, said at least one coil comprising an electrode for delivering energy and at least a first loop and a second loop, said first loop having a diameter differing from said second loop, the proximal end of the at least one coil being slidably translatable along the elongated member.
2. The removable device of claim 1 , wherein said energy delivery element is maintained in a non-coiled state within said sheath lumen and wherein said energy delivery element forms said at least one coil when the energy delivery element is deployed beyond the distal end of said sheath.
3. The removable device of claim 1 wherein said energy delivery element comprises a shape memory alloy.
4. The removable device of claim 3, wherein said shape memory alloy is nitinol.
5. The removable device of claim 1, wherein said at least one coil is a spiral shaped coil.
6. (Canceled)
7. (Canceled)
8. The removable device of claim 1, wherein said energy delivery source supplies RF energy to said energy delivery element.
9. (Canceled)
10, (Canceled)
IL (Canceled)
12. (Canceled)
13. (Canceled)
14. (Canceled)
15. The removable device of claim 1» wherein said energy delivery element further comprises a coating of releasable material for depositing into a PFO tunnel.
16. The removable device of claim 15, wherein said coating of releasable material comprises a sleeve.
17- The removable device of claim.15, wherein said releasable material that is deposited into a PFO tunnel is selected from the group consisting of a polymer, a bioabsorbable material, a growth stimulating material, and a metal with a low melting point.
15. (Canceled)
19. (Canceled)
20. The removable device of claim 1, further comprising a push rod slidably moveable within the sheath and coaxial with the elongated member, wherein the proximal end of the at least one coil is slidably translatable along the elongated member from the proximal end of the elongated member towards the distal end of the elongated member by distal movement of the push rod.
21. The removable device of claim 1, wherein the at least one coil of said energy delivery element is releasably. attached at its distal end to the distal end of tli© elongated member.
22. A device for occluding a patent foramen ovale (PFO) in a patieiit comprising: a sheath comprising a lumen; an elongated member, at leapt one of said elongated member and said sheath axially moveable relative to the other; and an energy delivery element comprising a first braided portion, a second braided portion, and a non-braided portion, wherein the first braided portion and the second braided portion are separated by a non-braided portion wherein said energy delivery element is coupled to said elongated member to facilitate deployment and removal of said energy delivery element at said PFO.
23. The device of claim 22: wherein the surface of said first or second braided portion comprises nodes for delivery of energy.
24. The device of claim 22, wherein said energy delivery element is designed to distribute energy to at least one linear pathway along die first or second braided portion,
25. The device of claim, 22, wherein said energy delivery element is designed to distribute energy to the entire surface of the first or second braided portion.
26. The device of claim 22, wherein said first braided porti on comprises a clamp that when eneraized ensaeea a sft-ntal wall of τhι* PPn
19. (Canceled)
20. The removable device of claim I5 further comprising a push rod slidably moveable within the sheath and coaxial with the elongated member, wherein the proximal end of the at least one coil is slidably translatable along the elongated member from the proximal end of the elongated member towards the distal end of the elongated member by distal movement of the push rod.
21. The removable device of claim 1, wherein the at least one coil of said energy delivery element is releasably attached at its distal end to the distal end of tlie elongated member.
22. A device for occluding a patent foramen ovale (PFO) in a patient comprising: a sheath comprising a lumen; an elongated member, at least oue of said elongated member and said sheath axially moveable relative to the other; and an energy delivery element comprising a first braided portion, a second braided portion, and a non-braided portion, wherein the first braided portion and the second braided portion are separated by a non-braided portion wherein said energy delivery element is coupled to said elongated member to facilitate deployment and removal of said energy delivery element at said PFO,
23. The device of claim 22, wherein the surface of said first or second braided portion comprises nodes for delivery of energy.
24, The device of claim 22, wherein said energy delivery element is designed to distribute energy to at least one linear pathway along die first or second braided portion.
25. The device of claim 22, wherein said energy delivery element is designed to distribute energy to the entire surface of the first or second braided portion.
26. The device of claim 22, wherein said first braided porti on comprises a clamp that when energized engages a septal wall of the PFO.
27. The device of claim 22, wherein said first braided portion or said second braided portion comprises a releasable coating that is deposited m a tunnel of the PFO.
28. The device of claim 27, wherein the releasable coating is selected from the group consisting of a polymer, a bioabsorbable material, a growth stimulating material, and a metal with a low melting point.
29. The device of claim 22, further comprising a device for applying negative pressure to the septum primum and septum secundum of the PFO.
30. The device of claim 26, further comprising a second braided portion comprising a clamp.
31. A method for occluding a patent foramen ovale (PFO) in a patient comprising: passing a device through a tunnel of a PFO into a left atrium of a patient's heart, said device comprising a sheath comprising a proximal end, a distal end, and a lumen; an elongated member, one of said elongated member and said sheath axially moveable relative to the other; and an energy delivering element joined to said elongated member, wherein said energy delivery element comprises an occluding member comprising at least one occlusion shell; and an attachment device wherein said attachment device attaches said elongated member to the energy delivery element; deploying said occluding member on the left atrial side of the PFO by retracting said sheath; applying energy to the PFO via the energy delivering element; and detaching said occluding member from said elongated member and removing said elongate member from the PFO-
32. The method of claim 31, wherein said at least one occlusion shell is joined to a second occlusion shell.
33. The method of claim 32, wherein said second occlusion shell is deployed on a right atrial side of the PFO prior to the application of energy by the energy delivering element.
34. The method of claim 32, wherein said at least one occlusion shell comprises a plurality of outwardly extending proximal arms, and said second occlusion shell comprises a plurality of outwardly extending distal aims* wherein said at least one occlusion shell and said second occlusion shell are joined by a centering mechanism secured between said at least one occlusion shell and said second occlusion shell, said centering mechanism comprising at least two centering members, each of said centering members secured between a separate one of said proximal arras and a corresponding one of said distal arm?, at least one of said centering members comprising an elastomeric material.
35. The method of claim 31 , wherein said attachment device between said elongated member and said energy delivery element is insulated.
36. The method of claim 31, "wherein said attachment device is insulated "by a coating of non-conductive material.
37. The method of claim 31 , wherein said attachment device is insulated by a sleeve of non-conductive material.
38. The method of claim 313 wherein said occluding member comprises a resorbable material.
39. The method of claim 31 , wherein the attachment device comprises a ball and socket connection.
40. The method of claim 31, wherein the attachment device comprises a magnetic connection.
41. The method of claim 31 , wherein the attachment device comprises a looped connection.
42. The method of claim 31 , further comprising a vacuum element for applying a vacuum force to a septum primura and septum secundum the PFO.
43. The method of claim 31 , wherein the occluding member is removable.
44. A medical device for occluding the tunnel of a patent foramen ovale (PFO) in a patient comprising; a sheath comprising a lumen; an elongated member, one of saicl elongated member and said sheath axially moveable relative to the other; and an energy delivering element comprising a plug comprising animal tissue and joined to said elongated member, wherein said plug comprises a core member sized and, shaped to substantially fill the tunnel of the PFO. 45. The device of clai m 44, wherein said plug comprises a resorbable material.
46. The device of claim 44, wherein said plug is expandable.
47. The device of claim 46, wherein said plug is expandable upon application of energy to the plug. 48, The device of claim 44. wherein the energy delivering element delivers RF energy.
49. The device of claim 48, wherein the RF energy is supplied to one or more points on said plug.
50. The device of claim 48, wherein the RF energy is supplied along one or more linear pathways of the plug.
51. The device of claim 48, wherein the KF energy is supplied to the entire plug-
52. The device of claim 44, further comprising an occluding member.
53. The device of claim 52, wherein the occluding member comprises a bϊoabsorbable material.
54. The device of claim 52, wherein the occluding member comprises a proximal occluder including a plurality of outwardly extending proximal arms supporting a proximal occlusion shell and a distal occluder including a plurality of outwardly extending distal arras supporting a distal occlusion shell and a centering mechanism secured between said proximal occluder and said distal occluder to center said proximal and said distal occluders about a, defect, said centering mechanism comprising at least two centering members, each of said centering members secured between a separate one of said proximal arms and a corresponding one of said distal arms, at least one of said centering members comprising an elastomeric material.
55. The device of claim 44, wherein the plug further comprises a sleeve or coating which bonds to tissue of the PFO upon application of energy. 56- The device of claim 44, wherein the sleeve or coating comprises a material from the group consisting of a bioabsorbable material, a ρolymer7 and a metal. 57. The device of claim 44, wherein the sleeve or coating comprises one or more substances for stimulating tissue growth. 58. The device of claim 44, wherein the occluding member comprises a spiral shaped device.
59- The device of claim 44, wherein the occluding member comprises nitinol or a bioabsorbable material.
60. The device of claim 44, wherein the plug further comprises a shape memory alloy.
61. The device of claim 60 wherein the shape memory alloy is nitinol.
62. A removable device for occluding a patent foramen ovale (PFO) comprising: a sheath comprising a lumen; an elongated member, one of said sheath and said elongated member axially moveable relative to the other; and an energy delivery element comprising at least one curvilinear member wherein said energy delivery element is coupled to said elongated member to facilitate deployment and removal of said energy delivery element at said PFO, said at feast one curvilinear member comprising a releasable coaling for bonding to Ae tissues of the PFO.
63. The device of claim 62, wherein, the at least one curvilinear element is a hook,
64. The device of claim 62, further comprising an occluding member.
65. The device of claim 62, wherein said occluding member comprising an occlusion shell comprising a mesh fabric .
66. The device of claim 62, wherein said releasable coating is selected from the group consisting of a polymer, a bioabsorbable material, a growth stimulating material, and a metal with a low melting point.
67. The device of claim 62, wherein said curvilinear member comprises a shape memory alloy.
68. The device of claim 67, wherein said shape memory alloy is nitinol.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US71433205P | 2005-09-06 | 2005-09-06 | |
US60/714,332 | 2005-09-06 |
Publications (3)
Publication Number | Publication Date |
---|---|
WO2007030433A2 WO2007030433A2 (en) | 2007-03-15 |
WO2007030433A3 WO2007030433A3 (en) | 2007-06-14 |
WO2007030433B1 true WO2007030433B1 (en) | 2007-08-23 |
Family
ID=37478709
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2006/034504 WO2007030433A2 (en) | 2005-09-06 | 2006-09-06 | Removable intracardiac rf device |
Country Status (2)
Country | Link |
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US (2) | US7797056B2 (en) |
WO (1) | WO2007030433A2 (en) |
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2010
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WO2007030433A2 (en) | 2007-03-15 |
US7797056B2 (en) | 2010-09-14 |
US8795329B2 (en) | 2014-08-05 |
WO2007030433A3 (en) | 2007-06-14 |
US20100312236A1 (en) | 2010-12-09 |
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