Endovascular splinting devices and methods

• US 20070055303A1
• Filed: 10/06/2006
• Published: 03/08/2007
• Est. Priority Date: 10/06/2000
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Myocor, Inc. (Edwards Lifesciences Corporation)
• Inventors: Schroeder, Richard, Mortier, Todd, Keith, Peter, Vidlund, Robert, Simmon, Marc, Kalgreen, Jason, Schweich, Cyril
• Application Number:
  US11/543,892
• Publication Number:
  US 20070055303A1
• Time in Patent Office: Days
• US Class Current: 606/213
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00907 for light
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints

Abstract

A method for placing a splint assembly transverse a heart chamber includes providing an elongate member having a first end and a second end and a deployable heart-engaging assembly connected to at least the first end. The method includes advancing the elongate member through vasculature structure and into the heart chamber such that the first end of the elongate member extends through a first location of a wall surrounding the heart chamber and the second end extends through a second location of the heart chamber wall substantially opposite the first location. A deployable heart-engaging assembly is deployed such that it engages with a first exterior surface portion of the heart chamber wall adjacent the first location. The elongate member is secured with respect to the heart with a second heart-engaging assembly connected to the second end. The second heart-engaging assembly engages with a second exterior surface portion of the heart chamber wall adjacent the second location. A splint assembly includes an expandable heart-engaging assembly formed partially from portions forming the elongate member of the splint assembly. A delivery tool includes a tubular member configured to be advanced through vasculature structure and has a curved distal end.

Claims

1-56. -56. (canceled)

57. A system for remodeling a mitral valve annulus, comprising:

a delivery catheter;

an implant, detachably carried by the delivery catheter, the implant reversibly movable between a first, flexible configuration for delivery to a site adjacent the annulus of the mitral valve and a second, rigid configuration for remodeling the mitral valve annulus;

an elongate flexible control line having a first end attached to the implant and a second end spaced apart from the implant; and

a coupling on the second end for releasable coupling to an adjustment tool.

58. A system as in claim 57, wherein the implant comprises an arc when in the remodeling configuration.

59. A system as in claim 58, wherein the implant comprises a compound curve when in the remodeling configuration.

60. A system as in claim 59, wherein the compound curve comprises a “

w”

configuration.

61. A system as in claim 57, further comprising a coating on the implant.

62. A system as in claim 57, further comprising an anchor for retaining the implant at a deployment site.

63. A system as in claim 62, wherein the anchor comprises a distal extension of the implant.

64. A system as in claim 62, wherein the anchor comprises a friction enhancing surface structure for engaging adjacent tissue.

65. A system as in claim 57, wherein the implant is adjustable in response to rotation of the control line.

66. A system as in claim 57, wherein the implant is adjustable in response to axial movement of the control line.

67. A method of treating a patient, comprising the steps of:

identifying a patient having a control line connected to an implant residing within the patient;

accessing the control line at a site on the patient that is remote from the implant; and

manipulating the control line to adjust extravascular pressure exerted by the implant.

68. A method of treating a patient as in claim 67, wherein the identifying step comprises identifying a patient having an intravascular implant.

69. A method of treating a patient as in claim 67, wherein the manipulating step changes pressure exerted by the implant on the mitral valve.

70. A method of treating a patient, comprising the steps of:

locating a control line positioned subcutaneously on the patient;

exposing a portion of the control line; and

manipulating the control line to mechanically change the hemodynamic function of a heart valve.

71. A method of treating a patient as in claim 70, wherein the manipulating step comprises connecting an adjustment tool to the control line and using the adjustment tool to manipulate the control line.

72. A method of providing a therapeutic compressive force against a tissue structure which is adjacent an implant, comprising the steps of positioning a device at a target site in a patient;

the device connected by an elongate, flexible control line to a remote connector;

coupling an adjustment tool to the connector; and

actuating the adjustment tool to cause a portion of the device to move, thereby exerting a force against the adjacent tissue structure.

73. A method as in claim 72, wherein the positioning step is accomplished translumenally.

74. A method as in claim 72, wherein the positioning step is accomplished through an artificial tissue tract.

75. A method as in claim 72, wherein the positioning step is accomplished percutaneously.

76. A method as in claim 72, wherein the tissue structure comprises the mitral valve annulus.

77. A method as in claim 72, wherein the tissue structure comprises the left ventricle.

78. A method as in claim 76, wherein the positioning step comprises advancing the device translumenally through a vein.

79. A method as in claim 78, wherein the positioning step comprises percutaneously accessing the venous system prior to the positioning step.

80. A method as in claim 79, wherein the accessing step is accomplished by accessing one of the internal jugular, subclavian and femoral veins.

81. A method as in claim 72, further comprising the step of measuring hemodynamic function following the actuating step.