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US20020183839A1 Expired / Lapsed US ⏱️ 0.0 years remaining

Less-invasive devices and methods for treatment of cardiac valves

Assignee: Edwards Lifesciences LLC
•
Filing: 2002-07-18
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Granted: —
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Expires: 2022-07-18
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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 Garrison
  • 👤 Brian Donlon
  • 👤 S. Daniel
  • 👤 John Stevens

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-22 23:59
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: 23
Claim 1
Independent Claim 128 words
1 . A system for repairing a heart valve in a patient's heart, the heart being disposed within a chest cavity defined by a plurality of ribs, each rib being separated from an adjacent rib by an intercostal space having an intercostal width when the ribs are in an unretracted position, the system comprising: an annuloplasty device adapted for attachment within the heart around the heart valve; a device holder for releasably holding the annuloplasty device; and an elongated handle for delivering the device holder and annuloplasty device through a percutaneous penetration in the intercostal space, 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 smaller than the intercostal width.
Claim 2
Dependent Claim 128 words
1 . A system for repairing a heart valve in a patient's heart, the heart being disposed within a chest cavity defined by a plurality of ribs, each rib being separated from an adjacent rib by an intercostal space having an intercostal width when the ribs are in an unretracted position, the system comprising: an annuloplasty device adapted for attachment within the heart around the heart valve; a device holder for releasably holding the annuloplasty device; and an elongated handle for delivering the device holder and annuloplasty device through a percutaneous penetration in the intercostal space, 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 smaller than the intercostal width.
Claim 3
Dependent Claim 34 words
2 . The system of claim 1 further comprising a retraction means for retracting tissue in the percutaneous penetration to facilitate positioning the annuloplasty device therethrough while leaving the ribs in the unretracted position.
Claim 4
Dependent Claim 50 words
3 . The system of claim 2 wherein the retraction means comprises a cannula having a distal end positionable in the chest cavity through the intercostal space, a proximal end, and an inner lumen through which the annuloplasty device and device holder may be positioned while attached to the handle.
Claim 5
Dependent Claim 31 words
4 . 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 50 words
5 . 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 20 words
6 . 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 21 words
7 . The system of claim 4 wherein the inner lumen has a shape selected from oval, racetrack, rectangular, and trapezoidal.
Claim 9
Dependent Claim 27 words
8 . The system of claim 3 further comprising an obturator removably positionable in the inner lumen to facilitate introduction of the cannula through the percutaneous penetration.
Claim 10
Dependent Claim 26 words
9 . The system of claim 2 further comprising a suture organizing means for retaining a plurality of sutures in preselected positions outside the chest cavity.
Claim 11
Dependent Claim 18 words
10 . The system of claim 9 wherein the suture organizing means is attached to the retraction means.
Claim 12
Dependent Claim 56 words
11 . The system of claim 10 wherein the retraction means comprises a cannula having a distal end positionable in the chest cavity through the intercostal space, a proximal end, and an inner lumen, and the suture organizing means comprises a plurality of slots disposed in a proximal end of the cannula around the inner lumen.
Claim 13
Dependent Claim 19 words
12 . The system of claim 1 wherein the handle has a length of at least about 20 cm.
Claim 14
Dependent Claim 17 words
13 . The system of claim 1 wherein the profile height is less than about 25 mm.
Claim 15
Dependent Claim 72 words
14 . The system of claim 1 wherein a bottom side of the annuloplasty device is configured to be positioned in contact with an internal wall of the heart around the heart valve. the bottom side defining a first plane, and wherein the device holder is configured to attach to the handle such that a longitudinal axis of the handle is at an angle of about 0°+/−45° relative to the first plane.
Claim 16
Dependent Claim 68 words
15 . The system of claim 14 wherein the device holder is pivotably coupled to the handle so as to be pivotable about an axis perpendicular to the longitudinal axis of the handle between a first orientation in which the annuloplasty device may be positioned through the intercostal space and a second orientation in which the annuloplasty device may be secured in the heart around the heart valve.
Claim 17
Dependent Claim 45 words
16 . The system of claim 15 wherein, in the first orientation, the first plane is at an angle of 0°+/−45° relative to the longitudinal axis, and in the second orientations the first plane is at an angle of 90°+/−20° relative to the longitudinal axis.
Claim 18
Dependent Claim 30 words
17 . The system of claim 15 wherein the handle further comprises an actuator at a proximal end thereof for pivoting the device holder between the first and second orientations.
Claim 19
Dependent Claim 23 words
18 . The system of claim 1 wherein the device holder includes retention means for retaining the annuloplasty device on the device holder.
Claim 20
Dependent Claim 139 words
19 . A method of repairing a heart valve in a patient's heart, the heart being disposed within a chest cavity defined by a plurality of ribs attached to a sternum, each rib being separated from an adjacent rib by an intercostal space having an intercostal width when the ribs are in an unretracted position, the method comprising: establishing cardiopulmonary bypass; arresting the patient's heart; forming a percutaneous penetration into the chest cavity through an intercostal space; forming a cardiac penetration into the heart through an outer wall of the heart; positioning an annuloplasty device through the percutaneous penetration and the cardiac penetration into the heart; and securing the annuloplasty device to an internal wall of the heart around the heart valve; wherein each of the above steps are performed with the ribs and sternum intact and substantially unretracted.
Claim 21
Dependent Claim 139 words
19 . A method of repairing a heart valve in a patient's heart, the heart being disposed within a chest cavity defined by a plurality of ribs attached to a sternum, each rib being separated from an adjacent rib by an intercostal space having an intercostal width when the ribs are in an unretracted position, the method comprising: establishing cardiopulmonary bypass; arresting the patient's heart; forming a percutaneous penetration into the chest cavity through an intercostal space; forming a cardiac penetration into the heart through an outer wall of the heart; positioning an annuloplasty device through the percutaneous penetration and the cardiac penetration into the heart; and securing the annuloplasty device to an internal wall of the heart around the heart valve; wherein each of the above steps are performed with the ribs and sternum intact and substantially unretracted.
Claim 22
Dependent Claim 164 words
20 . An adaptor to facilitate delivering an annuloplasty device into a patient's heart for repairing a heart valve therein, the annuloplasty device being mounted on a holder having a fitting for connection to a handle, and the heart being disposed within a chest cavity defined by a plurality of ribs, each rib being separated from an adjacent rib by an intercostal space having an intercostal width when the ribs are in an unretracted position, the adaptor comprising: a body having a distal end and a proximal end; a proximal connector on the proximal end adapted for connection to a delivery handle; and a distal connector on the distal end adapted for connection to the fitting on the holder; wherein the proximal connector is adapted to connect to the delivery handle along a first axis, and the distal connector is adapted to connect to the fitting along a second axis, the first axis being at an angle of 90°+/−45° relative to the second axis.
Claim 23
Dependent Claim 164 words
20 . An adaptor to facilitate delivering an annuloplasty device into a patient's heart for repairing a heart valve therein, the annuloplasty device being mounted on a holder having a fitting for connection to a handle, and the heart being disposed within a chest cavity defined by a plurality of ribs, each rib being separated from an adjacent rib by an intercostal space having an intercostal width when the ribs are in an unretracted position, the adaptor comprising: a body having a distal end and a proximal end; a proximal connector on the proximal end adapted for connection to a delivery handle; and a distal connector on the distal end adapted for connection to the fitting on the holder; wherein the proximal connector is adapted to connect to the delivery handle along a first axis, and the distal connector is adapted to connect to the fitting along a second axis, the first axis being at an angle of 90°+/−45° relative to the second axis.

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