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Less-invasive devices and methods for treatment of cardiac valves

Assignee: Edwards Lifesciences LLC

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Filing: 1997-10-21

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Granted: 1999-10-26

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Expires: 2017-10-21

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Abstract

Abstract Devices and methods are provided for less-invasive surgical treatment of cardiac valves whereby the need for a gross thoracotomy or median sternotomy is eliminated. In one aspect of the invention, a delivery system for a cardiac valve prosthesis such as an annuloplasty ring or prosthetic valve includes an elongated handle configured to extend into the heart through an intercostal space from outside of the chest cavity, and a prosthesis holder attached to the handle for releasably holding a prosthesis. The prosthesis holder is attached to the handle in such a way that the holder, prosthesis and handle have a profile with a height smaller than the width of an intercostal space when the adjacent ribs are unretracted, preferably less than about 30 mm. In a further aspect, the invention provides a method for repairing or replacing a heart valve which includes the steps of introducing a prosthesis through an intercostal space and through a penetration in a wall of the heart, and securing the prosthesis to an interior wall of the heart, wherein each step is carried out without cutting, removing, or significantly retracting the ribs or sternum.

Inventors

👤 Michi E. Garrison
👤 Brian S. Donlon
👤 S. Christopher Daniel
👤 John H. Stevens

Bibliographic Details

Application Number —

Jurisdiction US

Data Source google_patents

Last Synchronized 2026-10-23 13:11

CPC Classifications

A; A61; A61B; A61B17/00; A61B17/0057; A61B17/00234; A61B17/02; A61B17/0218; A61B17/0293; A61B17/04; A61B17/0469; A61B17/06; A61B17/06061; A61B17/12; A61B17/122; A61B17/28; A61B17/29; A61B17/34; A61B17/3417; A61B17/3421; A61B18/00; A61B18/04; A61B18/12; A61B18/14; A61B18/1492; A61B90/00; A61B90/36; A61B90/50; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2427; A61F2/2442; A61F2/2445; A61F2/2448; A61F2/2466; A61F2/2496; A61F7/00; A61F7/10; A61M; A61M39/00; A61M39/02; A61M39/0247; A61B17/0467; A61B17/2909; A61B2017/00017; A61B2017/00022; A61B2017/00039; A61B2017/00044; A61B2017/00048; A61B2017/00053; A61B2017/00238; A61B2017/00243; A61B2017/00247; A61B2017/00575; A61B2017/00831; A61B2017/00867; A61B2017/00902; A61B2017/00907; A61B2017/00946; A61B2017/0237; A61B2017/0243; A61B2017/047; A61B2017/0472; A61B2017/0474; A61B2017/0475; A61B2017/0496; A61B2017/2912; A61B2017/2926; A61B2017/2927; A61B2017/2932; A61B2017/2943; A61B17/30; A61B2017/306; A61B2017/308; A61B17/3403; A61B2017/3405; A61B2017/348; A61B2017/3492; A61B2018/00053; A61B2018/00214; A61B2018/0022; A61B2018/00232; A61B2018/0025; A61B2018/00261; A61B2018/00273; A61B2018/00291; A61B2018/00315; A61B2018/00345; A61B2018/00351; A61B2018/00363; A61B2018/00392; A61B2018/00571; A61B2018/00577; A61B2018/00982; A61B90/06; A61B2090/061; A61B90/30; A61B2090/306; A61F2007/0001; A61F2007/0054; A61F2007/101; A61M1/00; A61M1/36; A61M1/3621; A61M25/00; A61M25/01; A61M25/02; A61M2025/028; A61M2039/027; A61M2039/0279; A61M2202/00; A61M2202/04; A61M2202/0468; A61M2202/047; A61M2205/00; A61M2205/33; A61M2205/3331; A61M2205/3344; A61M2205/3355; A61M2205/36; A61M2205/366; A61M25/10; A61M25/1011

Claims Analysis

Total Claims: 34

Claim 1

Independent Claim 148 words

Claim 2

Independent Claim 148 words

Claim 3

Dependent Claim 28 words

The system of claim 1 further comprising a retractor sized and configured to retract tissue around the opening in the patient to facilitate positioning the annuloplasty device therethrough.

Claim 4

Dependent Claim 48 words

The system of claim 2 wherein the retractor includes a cannula having a distal end positionable in the chest cavity through an intercostal space, a proximal end, and an inner lumen through which the annuloplasty device and the device holder may be positioned while attached to the handle.

Claim 5

Dependent Claim 29 words

The system of claim 3 wherein the inner lumen of the cannula has a cross-sectional height and a cross-sectional width, the cross-sectional height being larger than the cross-sectional width.

Claim 6

Dependent Claim 48 words

The system of claim 4 wherein the annuloplasty device has a device width in a direction perpendicular to the profile height, the cross-sectional height of the inner lumen being larger than the device width, and the cross-sectional width of the inner lumen being larger than the profile height.

Claim 7

Dependent Claim 18 words

The system of claim 5 wherein the cross-sectional height is at least about 1.5 times the cross-sectional width.

Claim 8

Dependent Claim 18 words

The system of claim 4 wherein the inner lumen has a shape selected from oval, rectangular, and trapezoidal.

Claim 9

Dependent Claim 24 words

The system of claim 3 further comprising an obturator removably positionable in the inner lumen to facilitate introduction of the cannula through the opening.

Claim 10

Dependent Claim 30 words

The system of claim 2 further comprising a suture organizer having a number of suture holders configured to retain a plurality of sutures in positions outside the patient's chest cavity.

Claim 11

Independent Claim 178 words

A system for repairing a heart valve in a patient's heart, the system comprising: an annuloplasty device configured for attachment within the heart around the heart valve, the annuloplasty device having an attachment portion configured to be attached to a patient's heart, the attachment portion generally defining a plane; a device holder releasably coupled to the annuloplasty device; an elongated handle for delivering the device holder and the annuloplasty device through an opening in a patient's chest, the handle being attached to the device holder such that the handle, the device holder, and the annuloplasty device together have a profile with a profile height of less than 30 mm, the profile height being in a direction perpendicular to the plane defined by the attachment portion; a retractor sized and configured to retract tissue around the opening in the patient to facilitate positioning the annuloplasty device therethrough; and a suture organizer having a number of suture holders configured to retain a plurality of sutures in positions outside the patient's chest cavity; the suture organizer being attached to the retractor.

Claim 12

Independent Claim 178 words

Claim 13

Independent Claim 215 words

Claim 14

Independent Claim 215 words

Claim 15

Dependent Claim 17 words

The system of claim 1 wherein the handle has a length of at least about 20 cm.

Claim 16

Dependent Claim 47 words

The method of claim 12 wherein the second vascular graft is selected from the group including a left internal mammary artery, a right internal mammary artery, a gastroepiploic artery, a radial artery, an inferior epigastric artery, a splenic artery, a saphenous vein, and a prosthetic vascular graft.

Claim 17

Dependent Claim 24 words

The system of claim 1 wherein the handle has a longitudinal axis which is at an angle of about 0°+/-45° relative to the plane.

Claim 18

Dependent Claim 15 words

The system of claim 1 wherein the device holder is pivotably coupled to the handle.

Claim 19

Dependent Claim 64 words

The system of claim 15 wherein the device holder is pivotable relative to the handle between a first position and a second position, the handle having a longitudinal axis which forms an angle of 0°+/-45° relative to the plane when in the first position, the longitudinal axis of the handle forming an angle of 90°+/-20° relative to the plane when in the second position.

Claim 20

Dependent Claim 22 words

The system of claim 15 wherein the handle further comprises an actuator at a proximal end thereof for pivoting the device holder.

Claim 21

Dependent Claim 20 words

The system of claim 1 wherein the device holder includes means for retaining the annuloplasty device on the device holder.

Claim 22

Dependent Claim 25 words

The system of claim 18 wherein the retention means comprises at least one suture fastened to the device holder and extending around the annuloplasty device.

Claim 23

Dependent Claim 28 words

The system of claim 19 further comprising a groove or ridge on the device holder oriented transversely to the suture for guiding a cutting edge across the suture.

Claim 24

Dependent Claim 20 words

The system of claim 18 wherein the retention means comprises a flange around a lateral edge of the device holder.

Claim 25

Dependent Claim 44 words

The system of claim 21 wherein the retention means further comprises a retaining leaf movably coupled to the device holder, the retaining leaf being movable to a closed position in opposition to the flange to form a space therebetween for receiving the annuloplasty device.

Claim 26

Dependent Claim 40 words

The method of claim 21 wherein the heart is rotated about an axis disposed at an acute angle between 0 degrees and 90 degrees relative to a longitudinal axis extending from an aortic root toward an apex of the heart.

Claim 27

Dependent Claim 23 words

The system of claim 22 wherein the retaining leaf is pivotable about an axis perpendicular to a longitudinal axis of the annuloplasty device.

Claim 28

Dependent Claim 19 words

The system of claim 22 further comprising a catch for releasably locking the retaining leaf in the closed position.

Claim 29

Independent Claim 138 words

Claim 30

Independent Claim 138 words

Claim 31

Dependent Claim 18 words

The system of claim 26, further comprising: a pivoting mechanism attached to the distal portion of the handle.

Claim 32

Dependent Claim 46 words

The system of claim 26, wherein: the annuloplasty device being pivotable relative to the handle between a first position and a second position, the handle being substantially perpendicular to the plane in the first position and being substantially parallel to the plane in the second position.

Claim 33

Dependent Claim 42 words

The system of claim 26, wherein: the annuloplasty device, handle and holder have a profile height of less than 30 mm when the annuloplasty device is in the second position, the profile height being measured in a direction perpendicular to the plane.

Claim 34

Dependent Claim 35 words

The system of claim 26, wherein: the device holder has a recess extending in the direction of the plane, the recess having at least one opening; the handle having a coupling extending into the recess.

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USPTO Annuity & Maintenance Windows

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2002-10-25	2003-04-26	2003-10-26	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2006-10-25	2007-04-26	2007-10-26	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2010-10-25	2011-04-26	2011-10-26	$7700.00	Window Closed / Lapsed

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