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US6810882B2 Expired / Lapsed US ⏱️ 0.0 years remaining

Transluminal mitral annuloplasty

Assignee: Edwards Lifesciences AG
•
Filing: 2001-07-19
•
Granted: 2004-11-02
•
Expires: 2021-07-19
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Abstract

Abstract A mitral annuloplasty and left ventricle restriction device is designed to be transvenously advanced and deployed within the coronary sinus and in some embodiments other coronary veins. The device places tension on adjacent structures, reducing the diameter and/or limiting expansion of the mitral annulus and/or limiting diastolic expansion of the left ventricle. These effects may be beneficial for patients with dilated cardiomyopathy.

Inventors

  • 👤 Jonathan J. Langberg
  • 👤 Michael D. Lesh
  • 👤 Erik van der Burg

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 08:10
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2442; A61F2/2451; A61F2/2466

Claims Analysis

Total Claims: 67
Claim 1
Independent Claim 86 words
A method of performing transluminal mitral annuloplasty, comprising the steps of: providing a catheter, having a prosthesis thereon, the catheter having a rotatable member extending axially therethrough and releasably engaged with a rotatable component of the prosthesis; inserting the catheter into the venous system; transluminally advancing the prosthesis into the coronary sinus; rotating a component of the prosthesis to cause the prosthesis to exert a compressive force on adjacent atrial musculature; releasing the rotatable member from the prosthesis; and removing the rotatable member from the patient.
Claim 2
Independent Claim 86 words
A method of performing transluminal mitral annuloplasty, comprising the steps of: providing a catheter, having a prosthesis thereon, the catheter having a rotatable member extending axially therethrough and releasably engaged with a rotatable component of the prosthesis; inserting the catheter into the venous system; transluminally advancing the prosthesis into the coronary sinus; rotating a component of the prosthesis to cause the prosthesis to exert a compressive force on adjacent atrial musculature; releasing the rotatable member from the prosthesis; and removing the rotatable member from the patient.
Claim 3
Dependent Claim 22 words
The method of claim 1 , further comprising the step of percutaneously accessing the venous system prior to the transluminally advancing step.
Claim 4
Dependent Claim 30 words
The method of claim 2 , wherein the accessing step is accomplished by accessing one of the veins selected from the group consisting of internal jugular, subclavian and femoral veins.
Claim 5
Dependent Claim 28 words
The method of claim 1 , further comprising the steps of first measuring the coronary sinus and then selecting an appropriately sized prosthesis prior to the inserting step.
Claim 6
Dependent Claim 18 words
The method of claim 1 , further comprising the step of measuring hemodynamic function following the rotating step.
Claim 7
Dependent Claim 24 words
The method of claim 5 , further comprising the steps of determining an ongoing drug therapy taking into account the post implantation hemodynamic function.
Claim 8
Dependent Claim 21 words
The method of claim 1 , wherein the rotating a component step causes the prosthesis to bend into an arcuate configuration.
Claim 9
Dependent Claim 18 words
The method of claim 7 , further comprising the step of locking the prosthesis in the arcuate configuration.
Claim 10
Dependent Claim 21 words
The method of claim 8 , wherein the locking step comprises engaging a first threaded surface with a second threaded surface.
Claim 11
Dependent Claim 15 words
The method of claim 8 , wherein the locking step comprises providing an interference fit.
Claim 12
Dependent Claim 15 words
The method of claim 8 , wherein the locking step comprises providing an adhesive bond.
Claim 13
Dependent Claim 14 words
The method of claim 8 , wherein the locking step comprises providing a knot.
Claim 14
Dependent Claim 15 words
The method of claim 8 , wherein the locking step comprises providing a compression fit.
Claim 15
Dependent Claim 18 words
The method of claim 1 , further comprising the step of deploying the prosthesis in the coronary sinus.
Claim 16
Dependent Claim 18 words
The method of claim 14 , further comprising the step of removing the catheter from the venous system.
Claim 17
Dependent Claim 19 words
The method of claim 1 , additionally comprising the step of monitoring hemodynamic function to assess mitral valve regurgitation.
Claim 18
Dependent Claim 19 words
The method of claim 16 , wherein the monitoring step comprises monitoring hemodynamic function prior to the rotating step.
Claim 19
Dependent Claim 18 words
The method of claim 16 , wherein the monitoring step comprises monitoring hemodynamic function during the rotating step.
Claim 20
Dependent Claim 18 words
The method of claim 16 , wherein the monitoring step comprises monitoring hemodynamic function following the rotating step.
Claim 21
Dependent Claim 26 words
The method of claim 16 , wherein the rotating step results in axially moving a forming element with respect to the prosthesis, to bend the prosthesis.
Claim 22
Dependent Claim 16 words
The method of claim 16 , wherein the transluminally advancing step is accomplished using a catheter.
Claim 23
Dependent Claim 28 words
The method of claim 16 , further comprising the steps of first measuring the coronary sinus and then selecting an appropriately sized prosthesis prior to the inserting step.
Claim 24
Dependent Claim 19 words
The method of claim 16 , wherein the step of monitoring hemodynamic function is accomplished using transesophageal echo cardiography.
Claim 25
Dependent Claim 20 words
The method of claim 16 , wherein the step of monitoring hemodynamic function is accomplished using surface echo cardiographic imaging.
Claim 26
Dependent Claim 20 words
The method of claim 16 , wherein the step of monitoring hemodynamic function is accomplished using intracardiac echo cardiographic imaging.
Claim 27
Dependent Claim 20 words
The method of claim 16 , wherein the step of monitoring hemodynamic function is accomplished using fluoroscopy with radiocontrast media.
Claim 28
Dependent Claim 24 words
The method of claim 16 , wherein the step of monitoring hemodynamic function is accomplished using left atrial or pulmonary capillary wedge pressure measurements.
Claim 29
Dependent Claim 17 words
The method of claim 16 , further comprising the step of tightening the prosthesis to reduce regurgitation.
Claim 30
Dependent Claim 22 words
The method of claim 28 , wherein the tightening step is performed to achieve at least a one grade reduction in regurgitation.
Claim 31
Independent Claim 93 words
A method of performing transluminal mitral annuloplasty, comprising the steps of: providing a catheter, having a rotatable core extending therethrough and a prosthesis removably engaged with the core; inserting the catheter into the venous system; transluminally advancing the prosthesis into the coronary sinus; rotating the core to rotate a first component of the prosthesis with respect to a second component of the prosthesis; and releasing the prosthesis from the catheter, such that the rotatable core is disengaged from the prosthesis and the prosthesis exerts a force on the wall of the coronary sinus.
Claim 32
Independent Claim 93 words
A method of performing transluminal mitral annuloplasty, comprising the steps of: providing a catheter, having a rotatable core extending therethrough and a prosthesis removably engaged with the core; inserting the catheter into the venous system; transluminally advancing the prosthesis into the coronary sinus; rotating the core to rotate a first component of the prosthesis with respect to a second component of the prosthesis; and releasing the prosthesis from the catheter, such that the rotatable core is disengaged from the prosthesis and the prosthesis exerts a force on the wall of the coronary sinus.
Claim 33
Dependent Claim 22 words
The method of claim 30 , further comprising the step of percutaneously accessing the venous system prior to the transluminally advancing step.
Claim 34
Dependent Claim 30 words
The method of claim 31 , wherein the accessing step is accomplished by accessing one of the veins selected from the group consisting of internal jugular, subclavian and femoral veins.
Claim 35
Dependent Claim 28 words
The method of claim 30 , further comprising the steps of first measuring the coronary sinus and then selecting an appropriately sized prosthesis prior to the inserting step.
Claim 36
Dependent Claim 18 words
The method of claim 30 , further comprising the step of measuring hemodynamic function following the rotating step.
Claim 37
Dependent Claim 23 words
The method of claim 34 , further comprising the step of determining an ongoing drug therapy taking into account post implantation hemodynamic function.
Claim 38
Dependent Claim 31 words
The method of claim 30 , further comprising the step of changing the shape of the prosthesis from an implantation configuration to a remodeling configuration in response to the rotating step.
Claim 39
Dependent Claim 31 words
The method of claim 36 , wherein the prosthesis is reversibly movable between an implantation configuration for transluminal implantation and a remodeling configuration for exerting a force against a vessel wall.
Claim 40
Dependent Claim 17 words
The method of claim 36 , wherein the prosthesis defines an arc when in the remodeling configuration.
Claim 41
Dependent Claim 26 words
The method of claim 36 , wherein the changing the shape step comprises forming an arc which is concave in the direction of the mitral valve.
Claim 42
Dependent Claim 32 words
The method of claim 38 , wherein a best fit constant radius curve corresponding to the arc has a radius within the range of from about 10 mm to about 20 mm.
Claim 43
Dependent Claim 22 words
The method of claim 30 , further comprising the step of retaining the body in a remodeling configuration following the rotating step.
Claim 44
Dependent Claim 17 words
The method of claim 41 , wherein the retaining step comprises engaging a lock on the prosthesis.
Claim 45
Dependent Claim 13 words
The method of claim 42 , wherein the lock comprises an interference fit.
Claim 46
Dependent Claim 12 words
The method of claim 42 , wherein the lock comprises a ratchet.
Claim 47
Dependent Claim 25 words
The method of claim 42 wherein the lock comprises an engagement surface, which is movable between a first, disengaged configuration and a second, engaged configuration.
Claim 48
Dependent Claim 15 words
The method of claim 42 , wherein the lock is biased in a locked direction.
Claim 49
Dependent Claim 15 words
The method of claim 42 , wherein the lock is biased in an unlocked direction.
Claim 50
Dependent Claim 13 words
The method of claim 30 , further comprising a coating on the prosthesis.
Claim 51
Dependent Claim 25 words
The method of claim 30 , further comprising the step of deploying an anchor for retaining the prosthesis at a deployment site within a vessel.
Claim 52
Dependent Claim 16 words
The method of claim 49 , wherein the anchor comprises a distal extension of the implant.
Claim 53
Dependent Claim 22 words
The method of claim 49 , wherein the anchor comprises a friction enhancing surface structure for engaging the wall of the vessel.
Claim 54
Dependent Claim 25 words
The method of claim 49 , wherein the deploying an anchor step comprises deploying at least one barb for piercing the wall of the vessel.
Claim 55
Dependent Claim 20 words
The method of claim 30 , wherein the prosthesis has an axial length of no more than about 10 cm.
Claim 56
Dependent Claim 23 words
The method of claim 30 , wherein the cross sectional area through the implant is no more than about 10 mm 2 .
Claim 57
Dependent Claim 19 words
The method of claim 30 , additionally comprising the step of monitoring hemodynamic function to assess mitral valve regurgitation.
Claim 58
Dependent Claim 19 words
The method of claim 55 , wherein the monitoring step comprises monitoring hemodynamic function prior to the rotating step.
Claim 59
Dependent Claim 18 words
The method of claim 55 , wherein the monitoring step comprises monitoring hemodynamic function during the rotating step.
Claim 60
Dependent Claim 18 words
The method of claim 55 , wherein the monitoring step comprises monitoring hemodynamic function following the rotating step.
Claim 61
Dependent Claim 19 words
The method of claim 55 , wherein the step of monitoring hemodynamic function is accomplished using transesophageal echo cardiography.
Claim 62
Dependent Claim 20 words
The method of claim 55 , wherein the step of monitoring hemodynamic function is accomplished using surface echo cardiographic imaging.
Claim 63
Dependent Claim 20 words
The method of claim 55 , wherein the step of monitoring hemodynamic function is accomplished using intracardiac echo cardiographic imaging.
Claim 64
Dependent Claim 20 words
The method of claim 55 , wherein the step of monitoring hemodynamic function is accomplished using fluoroscopy with radiocontrast media.
Claim 65
Dependent Claim 24 words
The method of claim 55 , wherein the step of monitoring hemodynamic function is accomplished using left atrial or pulmonary capillary wedge pressure measurements.
Claim 66
Dependent Claim 23 words
The method of claim 55 , further comprising the step of determining an ongoing drug therapy taking into account post implantation hemodynamic function.
Claim 67
Dependent Claim 26 words
The method of claim 30 , further comprising the step of locking the prosthesis to retain a compressive force on the annulus following the manipulating step.

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Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2007-11-02 2008-05-03 2008-11-02 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2011-11-02 2012-05-03 2012-11-02 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2015-11-02 2016-05-03 2016-11-02 $7700.00 Window Closed / Lapsed

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