CA2483024A1 - Device and method for modifying the shape of a body organ - Google Patents

Device and method for modifying the shape of a body organ Download PDF

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Publication number
CA2483024A1
CA2483024A1 CA002483024A CA2483024A CA2483024A1 CA 2483024 A1 CA2483024 A1 CA 2483024A1 CA 002483024 A CA002483024 A CA 002483024A CA 2483024 A CA2483024 A CA 2483024A CA 2483024 A1 CA2483024 A1 CA 2483024A1
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CA
Canada
Prior art keywords
anchor
configuration
fixation member
assembly
lumen
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
CA002483024A
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French (fr)
Other versions
CA2483024C (en
Inventor
Mark L. Mathis
Leonard Kowalsky
David G. Reuter
Cruz Beeson
Gregory D. Nieminen
Ryan H. Braxtan
Nathan Aronson
Garrett R. Beget
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Cardiac Dimensions Pty Ltd
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Individual
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Filing date
Publication date
Priority claimed from US10/142,637 external-priority patent/US6824562B2/en
Priority claimed from US10/331,143 external-priority patent/US6793673B2/en
Application filed by Individual filed Critical Individual
Priority to CA2744868A priority Critical patent/CA2744868C/en
Publication of CA2483024A1 publication Critical patent/CA2483024A1/en
Application granted granted Critical
Publication of CA2483024C publication Critical patent/CA2483024C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2451—Inserts in the coronary sinus for correcting the valve shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A61F2250/001—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting a diameter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0059—Additional features; Implant or prostheses properties not otherwise provided for temporary

Abstract

An intravascular support device includes a support or reshaper wire (102), a proximal anchor (140) and a distal anchor (120). The support wire engages a vessel wall to change the shape of tissue adjacent the vessel in which the intravascular support is placed. The anchors and support wire are designed such that the vessel in which the support is placed remains open and can be accessed by other devices if necessary.

Claims (92)

1. A device that affects the condition of a mitral valve annulus of a heart comprising:
an elongated body dimensioned to be placed in the coronary sinus of the heart adjacent the mitral valve annulus;
a fixation member carried by the device, the fixation member being adjustable from a first configuration that permits placement of the device in the coronary sinus to a second configuration that anchors the device within the coronary sinus; and a lock that locks the fixation member in the second configuration.
2. The device of Claim 1 wherein the lock is releasable to release the fixation member from the second configuration to permit the device to be moved within the coronary sinus.
3. The device of Claim 1 wherein the fixation member is deformable to permit the device to be moved within the coronary sinus.
4. The device of Claim 1 wherein the fixation member is adjustable from the first configuration to a maximum second configuration and wherein the lock locks the fixation member intermediate the first configuration and the maximum second configuration.
5. The device of Claim 4 wherein the lock locks the fixation member at any one of a plurality of intermediate points between the first configuration and the maximum second configuration.
6. The device of Claim 1 wherein the fixation member is elongated and has a first end hingedly coupled to the device body, wherein the fixation member extends along the device body closely spaced to the device body when in the first configuration and wherein the fixation member is pivoted from the device body when in the second configuration to engage the coronary sinus and anchor the device in the coronary sinus.
7. The device of Claim 6 further comprising a support that renders the fixation member substantially rigid when in the second configuration.
8. The device of Claim 7 wherein the support is an extension of the fixation member, wherein the fixation member includes a second end opposite the first end and wherein the lock locks the fixation member second end on the device body.
9. The device of Claim 8 wherein the fixation member second end is slidable along the device body.
10. The device of Claim 8 wherein the device comprises a plurality of the fixation members.
11. The device of Claim 7 wherein the fixation member includes a second end opposite the first end, wherein the support comprises a support member having a first end hingedly coupled to the fixation member second end, wherein the support member has a second end opposite the support member first end, and wherein the lock locks the support member second end on the device body.
12. The device of Claim 11 wherein the support member second end is slidable along the device body.
13. The device of Claim 11 wherein the device comprises a plurality of the fixation members and support members.
14. An assembly that affects the condition of a mitral valve annulus of a heart, the assembly comprising:
a mitral valve therapy device dimensioned to be placed in the coronary sinus adjacent the mitral valve annulus, the device including an elongated body, a fixation member carried by the device, the fixation member being adjustable from a first configuration that permits placement of the device in the coronary sinus to a second configuration that anchors the device within the coronary sinus, and a lock that locks the fixation member in the second configuration; and a flexible catheter having a lumen that receives the device and being dimensioned to be advanced into the coronary sinus to place the device adjacent the coronary sinus.
15. The assembly of Claim 14 wherein the fixation member is adjustable from the first configuration to a maximum second configuration and wherein the lock locks the fixation member intermediate the first configuration and the maximum second configuration.
16. The assembly of Claim 15 wherein the lock locks the fixation member at any one of a plurality of intermediate points between the first configuration and the maximum second configuration.
17. The assembly of Claim 14 further comprising an elongated pusher that is received by the lumen of the catheter proximal to the device and that permits the device and the catheter to be moved opposite each other.
18. The assembly of Claim 14 further comprising a tether receivable by the catheter lumen and engagable with the device to pull the device distally with respect to the catheter.
19. The assembly of Claim 18 wherein the catheter transitions the fixation member from the first configuration to the second configuration.
20. The assembly of Claim 19 wherein the fixation member is elongated and has a first end hingedly coupled to the device body, wherein the fixation member extends along the device body when in the first configuration and wherein the fixation member is pivoted from the device body into the second configuration by distal movement of the catheter with respect to the device to engage the coronary sinus and anchor the device in the coronary sinus.
21. The assembly of Claim 20 wherein the device further comprises a support that renders the fixation member substantially rigid when in the second configuration.
22. The assembly of Claim 21 wherein the support is an extension of the fixation member, wherein the fixation member. includes a second end opposite the first end and wherein the lock locks the fixation member second end on the device body when the fixation member second end is in a locked position.
23. The assembly of Claim 22 wherein the fixation member second end is slidable along the device body by the catheter into the locked position.
24. The assembly of Claim 22 wherein the device comprises a plurality of the fixation members.
25. The assembly of Claim 21 wherein the fixation member includes a second end opposite the first end, wherein the support comprises a support member having a first end hingedly coupled to the fixation member second end, wherein the support member has a second end opposite the support member first end, and wherein the lock locks the support member second end on the device body when the support member second end is in a locked position.
26. The assembly of Claim 25 wherein the support member second end is slidable along the device body by the catheter into the locked position.
27. The assembly of Claim 26 wherein the device comprises a plurality of the fixation members and support members.
28. The assembly of Claim 14 wherein the lock is releasable to release the fixation member from the second configuration to permit the device to be removed from the coronary sinus.
29. The assembly of Claim 14 wherein the fixation member is deformable to permit the device to be moved within the coronary sinus.
30. An anchor that anchors, in a body lumen, a device having an elongated body dimensioned to be placed in the body lumen, the anchor comprising:
a fixation member carried on the device, the fixation member being adjustable from a first configuration that permits placement of the device in the body lumen to a second configuration that anchors the device within the body lumen; and a lock that locks the fixation member in the second configuration.
31. The anchor of Claim 30 wherein the lock is releasable to release the fixation member from the second configuration to permit the device to be moved within the body lumen.
32. The anchor of Claim 30 wherein the fixation member is deformable to permit the device to be moved within the body lumen.
33. The anchor of Claim 30 wherein the fixation member is adjustable from the first configuration to a maximum second configuration and wherein the lock locks the fixation member intermediate the first configuration and the maximum second configuration.
34. The anchor of Claim 33 wherein the lock locks the fixation member at any one of a plurality of intermediate points between the first configuration and the maximum second configuration.
35. The anchor of Claim 30 wherein the fixation member is elongated and has a first end hingedly coupled to the device body, wherein the fixation member extends along the device body closely spaced to the device body when in the first configuration and wherein the fixation member is pivoted from the device body when in the second configuration to engage the body lumen and anchor the device in the body lumen.
36. The anchor of Claim 35 further comprising a support that renders the fixation member substantially rigid when in the second configuration.
37. The anchor of Claim 36 wherein the support is an extension of the fixation member, wherein the fixation member includes a second end opposite the first end and wherein the lock locks the fixation member second end on the device body.
38. The anchor of Claim 37 wherein the fixation member second end is slidable along the device body.
39. The anchor of Claim 37 comprising a plurality of the fixation members.
40. The anchor of Claim 36 wherein the fixation member includes a second end opposite the first end, wherein the support comprises a support member having a first end hingedly coupled to the fixation member second end, wherein the support member has a second end opposite the support member first end, and wherein the lock locks the support member second end on the device body.
41. The anchor of Claim 40 wherein the support member second end is slidable along the device body.
42. The anchor of Claim 40 comprising a plurality of the fixation members and support members.
43. A device for modifying the shape of tissue adjacent to a lumen, the device comprising:
an anchor adapted to securely contact a lumen wall when the device is deployed in a lumen, the anchor having an unexpanded delivery configuration and an expanded deployed configuration;
a lock locking the anchor in its expanded deployed configuration; and a reshaper extending from the anchor and adapted to contact the lumen wall when the device is deployed in the lumen, the anchor comprising a flexible member extending from the reshaper in a curved path not parallel to the central axis of the lumen.
44. The device of Claim 43 wherein the lock comprises a locking element connected to the flexible member.
45. The device of Claim 43 wherein the flexible member is adapted to extend from the axis of the reshaper in at least a first place and a second place.
46. The device of Claim 45 wherein the flexible member comprises two arms extending from the first place and two arms extending from the second place.
47, The device of Claim 46 wherein the flexible member is adapted to have the two arms extending from the first place and the two arms extending from the second place meet at a third place.
48. The device of Claim 47 wherein the flexible member is adapted to have the third place outside of the axis of the reshaper.
49. The device of Claim 48 wherein the flexible member is formed in a bowed figure eight pattern.
50. The device of Claim 46 wherein the lock comprises a locking element connected to the flexible member.
51. The device of Claim 50 wherein the locking element comprises a loop connecting the two arms extending from the first place.
52. The device of Claim 51 wherein the locking element comprises a first locking element, the lock further comprising a second locking element connected to the reshaper.
53. The device of Claim 52 wherein the reshaper comprises a support wire, the second locking element comprising a bend in the support wire.
54. The device of Claim 52 wherein the second locking element comprises a camming surface extending from the reshaper.
55. The device of Claim 43 wherein the lock comprises a first locking element connected to the flexible member, the lock further comprising a second locking element connected to the reshaper.
56. The device of Claim 55 wherein the reshaper comprises a support wire, the second locking element comprising a bend in the support wire.
57. The device of Claim 55 wherein the second locking element comprises a camming surface extending from the reshaper.
58. The device of Claim 43 further comprising a crimp, the flexible member comprising two ends held by the crimp.
59. The device of Claim 58 wherein the flexible member is adapted to extend from an axis of the crimp in at least a first place and a second place, the first place comprising one end of the crimp.
60. The device of Claim 59 wherein the second place comprises another end of the crimp.
61. An assembly for affecting the condition of a mitral valve annulus of a heart comprising:
a mitral valve therapy device that reshapes the mitral valve annulus of the heart when placed within the coronary sinus of the heart adjacent the mural valve annulus, the mitral valve therapy device having a proximal end including a coupling structure;

a catheter having a lumen that directs the mitral valve therapy device into the coronary sinus of the heart;
a second coupling structure that is lockable on the device coupling structure;
and a locking member that locks the device coupling structure to the second coupling structure and that releases the device coupling structure from the second coupling structure.
62. The assembly of Claim 61 further including a pusher member that pushes the device through the catheter lumen, the pusher member having a distal end that engages the device proximal end.
63. The assembly of Claim 62 wherein the pusher member carries the second coupling structure at the distal end of the pusher member.
64. The assembly of Claim 61 wherein the device coupling structure comprises a hoop structure.
65. The assembly of Claim 64 wherein the second coupling structure comprises a hoop structure.
66. The assembly of Claim 65 wherein the locking member comprises a pin that extends through the hoop structures to lock the coupling structures together and that is retractable to release the hoop structures.
67. The assembly of Claim 66 wherein the catheter has a distal end and wherein the pin is elongated and extends through the distal end of the catheter.~
68. The assembly of Claim 66 further comprising a pusher member having a lumen and that pushes the device through the catheter lumen, the pusher member having a distal end that engages the device proximal end, a proximal end, and a lumen, and wherein the pin is elongated and extends through the pusher member lumen and out the pusher member proximal end.
69. The assembly of Claim 68 wherein the pusher member is an elongated coil.
70. The assembly of Claim 61 wherein the device coupling structure and the second coupling structure comprise a pair of interlocking structures and wherein the locking member comprises a slide-lock sheath closely fitted to the interlocking structures.
71. The assembly of Claim 70 wherein the interlocking structures are formed from tubing and wherein the slide-lock sheath is tubular.
72. The assembly of Claim 70 further including a pusher member that pushes the device through the catheter lumen, the pusher member having a distal end that engages the device proximal end, and wherein the pusher member carries the second coupling structure at the distal end of the pusher member.
73. The assembly of Claim 72 wherein the locking member further comprises a tether that extends from the slide-lock sheath to and through the catheter lumen to permit the tether to pull proximally on the slide-lock sheath for releasing the interlocking structures.
74. The assembly of Claim 61 further comprising a retractor configured to extend through the catheter lumen and grip the device coupler to permit retraction of the device through the catheter.
75. The assembly of Claim 74 further comprising a pusher member configured to extend through the catheter lumen and that pushes the device through the catheter lumen, the pusher member having a lumen and a distal end adapted to engage the device proximal end, and wherein the retractor is configured to extend down the pusher lumen to engage the device coupler.
76. An assembly for affecting the condition of a mitral valve annulus of a heart comprising:

device means for reshaping the mitral valve annulus of the heart when placed within the coronary sinus of the heart adjacent the mitral valve annulus, the device means having a proximal end including a coupling means for coupling the device means;
catheter means having a lumen that directs the mitral valve therapy device into the coronary sinus of the heart;
second coupling means for locking with the device coupling means; and locking means for locking the device coupling means to the second coupling means and releasing the device coupling means from the second coupling means.
77. The assembly of Claim 76 further comprising a pusher means for pushing the device means through the catheter means lumen, the pusher means having a lumen, and wherein the second coupling means and the locking means extend through the pusher means lumen.
78. The assembly of Claim 76 wherein the device coupling means and the second coupling means comprise interlocking means for releasably locking the device coupling means and the second coupling means, and wherein the locking means includes retaining means for retaining the interlocking means in an interlocked condition.
79. The assembly of Claim 78 wherein the retaining means is displaceable for releasing the interlocked condition of the interlocking means.
80. The assembly of Claim 76 further comprising retracting means for engaging the device coupling mews and removing the device means from the coronary sinus.
81. An assembly for effecting the condition of a mitral valve annulus of a heart comprising:
a mitral valve therapy device that reshapes the mitral valve annulus of the heart when placed within the coronary sinus of the heart adjacent the mitral valve annulus, the mitral valve therapy device having a proximal end including a coupling structure;

a guide member that directs the mitral valve therapy device into the coronary sinus of the heart;
a second coupling structure that is lockable on the device coupling structure;
and a locking member that locks the device coupling structure to the second coupling structure and that releases the device coupling structure from the second coupling structure.
82. An assembly for effecting the condition of a mitral valve annulus of a heart comprising:
device means for reshaping the mitral valve annulus of the heart when placed within the coronary sinus of the hear adjacent the mitral valve annulus, the device means having a proximal end including a coupling means for coupling the device means;
guide means for directing the mitral valve therapy device into the coronary sinus of the heart;
second coupling means for locking with the device coupling means; and locking means for locking the device coupling means to the second coupling means and releasing the device coupling means from the second coupling means.
83. A device for modifying the shape of tissue adjacent to a lumen, the device comprising:
an anchor adapted to be deployed by a catheter to engage the lumen;
a support extending from the anchor and adapted to engage the lumen; and a recapture mechanism adapted to assist the recapture of at least a portion of the device into the catheter.
84. The device of Claim 83 wherein the anchor comprises a proximal portion, the recapture mechanism comprising a surface on the proximal portion of the anchor adapted to guide the catheter over the device.
85. The device of Claim 84 wherein anchor is further adapted to expand after deployment from the catheter.
86. The device of Claim 85 wherein the recapture mechanism is adapted to assist in compression of the anchor.
87. The device of Claim 85 wherein the recapture mechanism comprises a first surface on the anchor and a second surface on the anchor, the slope of first surface with respect to a longitudinal axis of the anchor being less than the slope of the second surface with respect to the longitudinal axis of the anchor.
88. An intravascular support comprising:
a proximal anchor that circumferentially engages a vessel wall in which the support is placed, the proximal anchor being disposed in a proximal anchor plane;
a distal anchor that circumferentially engages a vessel wall in which the support is placed, the distal anchor being offset in a distal anchor plane offset from the proximal anchor plane; and a support wire extending between the proximal and distal anchors so that the support wire is urged against the vessel wall to compress tissue that is adjacent the vessel.
89. The intravascular support of claim 88 wherein the proximal anchor and the distal anchor each comprise a wire and a crimp connected to the wire.
90. The intravascular support of claim 89 wherein the proximal anchor and the distal anchor each comprise a plurality of wires.
91. The intravascular support of claim 90 wherein the crimp comprises a bore, the bore of the crimp having a non-circular shape adapted to accommodate and orient the wires.
92. The intravascular support of claim 91 wherein the bore is substantially square.
CA2483024A 2002-05-08 2003-05-02 Device and method for modifying the shape of a body organ Expired - Lifetime CA2483024C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2744868A CA2744868C (en) 2002-05-08 2003-05-02 Device and method for modifying the shape of a body organ

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US10/142,637 US6824562B2 (en) 2002-05-08 2002-05-08 Body lumen device anchor, device and assembly
US10/142,637 2002-05-08
US10/331,143 2002-12-26
US10/331,143 US6793673B2 (en) 2002-12-26 2002-12-26 System and method to effect mitral valve annulus of a heart
PCT/US2003/014007 WO2003094801A1 (en) 2002-05-08 2003-05-02 Device and method for modifying the shape of a body organ

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA2744868A Division CA2744868C (en) 2002-05-08 2003-05-02 Device and method for modifying the shape of a body organ

Publications (2)

Publication Number Publication Date
CA2483024A1 true CA2483024A1 (en) 2003-11-20
CA2483024C CA2483024C (en) 2011-09-13

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CA2877641A Expired - Lifetime CA2877641C (en) 2002-05-08 2003-05-02 Device and method for modifying the shape of a body organ
CA2744868A Expired - Lifetime CA2744868C (en) 2002-05-08 2003-05-02 Device and method for modifying the shape of a body organ
CA2950492A Expired - Lifetime CA2950492C (en) 2002-05-08 2003-05-02 Device and method for modifying the shape of a body organ
CA2483024A Expired - Lifetime CA2483024C (en) 2002-05-08 2003-05-02 Device and method for modifying the shape of a body organ

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CA2877641A Expired - Lifetime CA2877641C (en) 2002-05-08 2003-05-02 Device and method for modifying the shape of a body organ
CA2744868A Expired - Lifetime CA2744868C (en) 2002-05-08 2003-05-02 Device and method for modifying the shape of a body organ
CA2950492A Expired - Lifetime CA2950492C (en) 2002-05-08 2003-05-02 Device and method for modifying the shape of a body organ

Country Status (9)

Country Link
US (3) US7857846B2 (en)
EP (3) EP1513474B1 (en)
JP (2) JP4351151B2 (en)
AT (1) ATE417573T1 (en)
AU (2) AU2003228865B2 (en)
CA (4) CA2877641C (en)
DE (1) DE60325356D1 (en)
ES (1) ES2318130T3 (en)
WO (1) WO2003094801A1 (en)

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