CA2610796A1 - Patent foramen ovale closure device - Google Patents

Patent foramen ovale closure device Download PDF

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Publication number
CA2610796A1
CA2610796A1 CA002610796A CA2610796A CA2610796A1 CA 2610796 A1 CA2610796 A1 CA 2610796A1 CA 002610796 A CA002610796 A CA 002610796A CA 2610796 A CA2610796 A CA 2610796A CA 2610796 A1 CA2610796 A1 CA 2610796A1
Authority
CA
Canada
Prior art keywords
medical device
tubular structure
distal end
septum
closure
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002610796A
Other languages
French (fr)
Other versions
CA2610796C (en
Inventor
Chao Chin-Chen
Randy Grishaber
Gene Kammerer
Isaac John Khan
Jin Park
Daniel Olsen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cordis Corp
Original Assignee
Cordis Corporation
Chao Chin-Chen
Randy Grishaber
Gene Kammerer
Isaac John Khan
Jin Park
Daniel Olsen
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cordis Corporation, Chao Chin-Chen, Randy Grishaber, Gene Kammerer, Isaac John Khan, Jin Park, Daniel Olsen filed Critical Cordis Corporation
Priority to CA2801864A priority Critical patent/CA2801864C/en
Publication of CA2610796A1 publication Critical patent/CA2610796A1/en
Application granted granted Critical
Publication of CA2610796C publication Critical patent/CA2610796C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • 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
    • 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
    • A61B2017/00615—Implements with an occluder on one side of the opening and holding means therefor on the other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0409—Instruments for applying suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0419—H-fasteners

Abstract

A device and method for deploying a mechanical closure device for closing a passageway in a body, for example a patent foramen ovale (PFO) in a heart. The deployment device has a first tubular structure having proximal and distal ends. A second tubular structure is substantially coaxial to and slideably engaged within the first tubular structure. The second tubular structure has a first substantially linear shape when constrained within the first tubular structure, and a second curvilinear shape when telescopically extended from the distal end of the first tubular structure. A third tubular structure is substantially coaxial to and slideably engaged within the second tubular structure. The third tubular structure is configured to provide sufficient rigidity to push the mechanical closure device from the distal end of the second tubular structure, and provide sufficient flexibility to assume a curvilinear shape when deflected by the second tubular structure.

Claims (67)

1. A medical device for closing a passageway in a body comprising:

a closure line having a first and a second end;

a first expandable anchor connected to the first end of the closure line; and a second expandable anchor located along the second end of the closure line, the second expandable anchor having a locking mechanism integrated therein, the locking mechanism allowing the closure line to uni-axially slide through the second expandable anchor in one direction, and preventing sliding movement in the opposite direction.
2. The medical device of claim 1 wherein the closure line is elastic.
3. The medical device of claim 2 wherein the closure line is comprised of a linear-elastic material.
4. The medical device of claim 2 wherein the closure line is geometrically configured to exhibit elastic behavior.
5. The medical device of claim 4 wherein the closure line is comprised of a coil.
6. The medical device of claim 5 wherein the coil comprises a linear spring.
7. The medical device of claim 5 wherein the coil comprises a non-linear spring.
8. The medical device of claim 1 wherein the closure line is comprised of an anelastic material.
9. The medical device of claim 3 wherein the anelastic material is comprised of a family of elastomeric polymers.
10. The medical device of claim 1 wherein the closure line is comprised on a super elastic material.
11. The medical device of claim 4 wherein the super elastic material comprises a nickel titanium alloy.
12. The medical device of claim 1 wherein the closure line is a biocompatible filament.
13. The medical device of claim 12 wherein the biocompatible filament is a surgical suture.
14. The medical device of claim 13 wherein the surgical suture is a multifilament non-biodegradable suture.
15. The medical device of claim 12 wherein the surgical suture is a forced entangled fiber filament.
16. The medical device of claim 1 wherein the first and second expandable anchors are made from a structurally deformable material.
17. The medical device of claim 1 wherein the first and second expandable anchors are self-expanding.
18. The medical device of claim 17 wherein the first and second self-expanding anchors are made from a super elastic material.
19. The medical device of claim 18 wherein the super elastic material is a nickel titanium alloy.
20. The medical device of claim 18 wherein the super elastic material is a resilient polymer.
21. The medical device of claim 18 wherein the super elastic material is an elastically compressed spring temper biocompatible metal.
22. The medical device of claim 1 wherein the first and second expandable anchors are mechanically expandable.
23. The medical device of claim 22 wherein the first and second mechanically expandable anchors are made from a plastically deformable material.
24. The medical device of claim 23 wherein the plastically deformable material is spirally wound stainless steel.
25. A medical device for deploying a mechanical closure device to facilitate closing a passageway in a body comprising:

a first tubular structure having proximal and distal ends;
a second tubular structure substantially coaxial to and slideably engaged within the first tubular structure, the second tubular structure having a first substantially linear shape when constrained within the first tubular structure, and a second curvilinear shape when telescopically extended from the distal end of the first tubular structure; and a third tubular structure substantially coaxial to and slideably engaged within the second tubular structure, the third tubular structure configured to provide sufficient rigidity to push the mechanical closure device from the distal end of the second tubular structure, and provide sufficient flexibility to assume a curvilinear shape when deflected by the second tubular structure.
26. The medical device of claim 25 wherein the first tubular structure is rigid.
27. The medical device of claim 25 wherein the first tubular structure is between 5 and 30 French in diameter.
28. The medical device of claim 25 wherein the first tubular structure is made from a biocompatible material.
29. The medical device of claim 28 wherein the biocompatible material is surgical stainless steel.
30. The medical device of claim 28 wherein the biocompatible material is a nickel titanium alloy.
31. The medical device of claim 28 wherein the biocompatible material is a cobalt-chromium alloy.
32. The medical device of claim 25 wherein the distal end of the first tubular structure is tapered.
33. The medical device of claim 25 wherein the second tubular structure comprises shape memory material and is fabricated to resume a pre-determined configuration when telescoped from the distal end of the first tubular structure.
34. The medical device of claim 25 wherein the second tubular structure comprises a pullwire.
35. The medical device of claim 25 wherein the second tubular structure comprises bending regions.
36. The medical device of claim 35 wherein the bending regions comprise axially spiraling strain relief cuts.
37. The medical device of claim 35 wherein the bending regions comprise circumferential kerf cuts.
38. The medical device of claim 25 wherein the distal end of the second tubular structure is tapered.
39. The medical device of claim 25 wherein the third tubular structure comprises a super elastic material.
40. The medical device of claim 25 wherein the third tubular structure comprises longitudinally rigid, radially flexible regions.
41. The medical device of claim 40 wherein the longitudinally rigid, radially flexible regions comprises a biocompatible material tightly wound into a coil.
42. The medical device of claim 41 wherein the biocompatible material is stainless steel.
43. The medical device of claim 41 wherein the biocompatible material is a nickel titanium alloy.
44. The medical device of claim 41 wherein the biocompatible material is a cobalt-chromium alloy.
45. The medical device of claim 25 further comprising a location monitoring system.
46. The medical device of claim 45 wherein the location monitoring system comprises a localized pressure monitoring system.
47. The medical device of claim 46 wherein the localized pressure monitoring system comprises an electronic measuring means.
48. The medical device of claim 47 wherein the electronic measuring means comprises a solid-state pressure transducer.
49. The medical device of claim 46 wherein the localized pressure monitoring system comprises a mechanical measuring means.
50. The medical device of claim 49 wherein the mechanical measuring means comprises a spring loaded diaphragm.
51. The medical device of claim 49 wherein the mechanical measuring means comprises a communicating manometer.
52. The medical device of claim 46 wherein the localized pressure monitoring system comprises a physical measuring means.
53. The medical device of claim 52 wherein the physical measuring means comprises a hydraulic pressure port.
54. The medical device of claim 25 wherein the medical device further comprises a backup support device integrated along the distal end of the first tubular structure.
55. The medical device of claim 54 wherein the backup support device comprises an axially asymmetric expansion member.
56. The medical device of claim 54 wherein the axially asymmetric expansion member comprises a balloon.
57. The medical device of claim 54 wherein the axially asymmetric expansion member comprises a expandable cage.
58. The medical device of claim 54 wherein the axially asymmetric expansion member comprises a spline.
59. The medical device of claim 54 wherein the backup support device comprises imparting a shape along the distal end of the first tubular structure.
60. A method of deploying a mechanical closure device.
through the septum of a heart to facilitate closing of a patent foramen ovale comprising:
accessing the right atrium of the heart with a deployment device carrying the mechanical closure device, the mechanical closure device comprising a proximal and distal anchor with a closure line attached there between;
advancing the deployment device distally until the deployment device penetrates through the interatrial septum into the left atrium;
oienting the distal end of the deployment device back towards the interatrial septum;
advancing the deployment device until the distal end of the deployment device penetrates through the interatrial septum into the left atrium;
deploying the distal anchor from the distal end of the deployment device into the right atrium;
retracting the deployment device back from the right atrium to the left atrium, and then from the left atrium to the right atrium, leaving a portion of the closure line between the proximal and distal anchors in the left atrium;

deploying a proximal anchor associated with the mechanical closure device from the distal end of the deployment device into the right atrium.
61. The method of claim 60 wherein accessing the right atrium comprises accessing the right venous system and advancing the deployment device along the peripheral vein, into the region of the vena cavae, and into the right atrium.
62. The method of claim 60 wherein penetrating through the interatrial septum comprises penetrating through the septum primum and septum secundum.
63. The method of claim 60 wherein penetrating through the interatrial septum comprises penetrating through the septum primum.
64. The method of claim 60 wherein penetrating through the interatrial septum comprises penetrating through the septum secundum.
65. The method of claim 60 wherein orienting the distal end of the deployment device back towards the interatrial septum comprises imparting a curvilinear bend along the distal end of the deployment device.
66. The method of claim 60 further comprising uni-axially adjusting the mechanical closure device to bring the septum primum and septum secundum in close proximation.
67. The method of claim 60 further comprises assessing the proximation between the septum primum and septum secundum.
CA2610796A 2005-06-02 2006-06-02 Patent foramen ovale closure device Expired - Fee Related CA2610796C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2801864A CA2801864C (en) 2005-06-02 2006-06-02 Patent foramen ovale closure device

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US68686305P 2005-06-02 2005-06-02
US60/686,863 2005-06-02
US71338805P 2005-09-01 2005-09-01
US60/713,388 2005-09-01
PCT/US2006/021486 WO2006130836A2 (en) 2005-06-02 2006-06-02 Patent foramen ovale closure device

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA2801864A Division CA2801864C (en) 2005-06-02 2006-06-02 Patent foramen ovale closure device

Publications (2)

Publication Number Publication Date
CA2610796A1 true CA2610796A1 (en) 2006-12-07
CA2610796C CA2610796C (en) 2014-01-07

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA2610796A Expired - Fee Related CA2610796C (en) 2005-06-02 2006-06-02 Patent foramen ovale closure device

Country Status (9)

Country Link
US (3) US20070032821A1 (en)
EP (2) EP1887941B1 (en)
JP (1) JP2008541952A (en)
CN (1) CN101237823A (en)
AT (2) ATE519434T1 (en)
AU (1) AU2006252387B2 (en)
CA (1) CA2610796C (en)
DE (1) DE602006010370D1 (en)
WO (1) WO2006130836A2 (en)

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EP2135560A1 (en) 2009-12-23
EP1887941B1 (en) 2009-11-11
US8579933B2 (en) 2013-11-12
ATE519434T1 (en) 2011-08-15
DE602006010370D1 (en) 2009-12-24
WO2006130836A2 (en) 2006-12-07
CA2610796C (en) 2014-01-07
CN101237823A (en) 2008-08-06
WO2006130836A3 (en) 2007-04-12
US8777984B2 (en) 2014-07-15
US20130296924A1 (en) 2013-11-07
ATE447891T1 (en) 2009-11-15
US20070032820A1 (en) 2007-02-08
US20070032821A1 (en) 2007-02-08
AU2006252387B2 (en) 2012-03-15
JP2008541952A (en) 2008-11-27
EP1887941A2 (en) 2008-02-20
AU2006252387A1 (en) 2006-12-07

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