APPARATUS AND METHOD FOR MITRAL VALVE REPAIR WITHOUT CARDIOPULMONARY BYPASS, INCLUDING TRANSMURAL TECHNIQUES
First Claim
1. A method for repairing the mitral valve of a heart wherein at least one leaflet has suffered a defect with respect to its papillary muscle, said method comprising:
- introducing a clamp transmurally into the beating heart and through the papillary muscle;
grasping a portion of the leaflet with said clamp;
piercing a hole in the leaflet;
inserting a suture, having a first end, through said clamp and through said hole, said first end being displaced through said clamp instrument to emerge from a proximal end of said clamp;
removing said clamp from the beating heart; and
securing said first end, and a second end, of said suture against an exterior wall of the beating heart.
1 Assignment
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Accused Products
Abstract
A method and apparatus for repairing the heart'"'"'s mitral valve by using anatomic restoration without the need to stop the heart, use a heart-lung machine or making incisions on the heart. The method involves inserting a leaflet clamp through the heart'"'"'s papillary muscle from which the leaflet has been disconnected, clamping the leaflet'"'"'s free end and then puncturing the leaflet. One end of a suture is then passed through the hollow portion of the clamp, while the other end of the suture is maintained external to the heart. The clamp is then removed and the suture'"'"'s two ends are fastened together with a securement ring/locking cap assembly to the heart wall exterior, thereby reconnecting the leaflet to the corresponding papillary muscle. The introduction of the clamp, puncturing of the leaflet, passage of the suture therethrough and removal of the clamp can be conducted a plurality of times before each suture'"'"'s two ends are fastened to the securement ring/locking cap assembly.
214 Citations
40 Claims
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1. A method for repairing the mitral valve of a heart wherein at least one leaflet has suffered a defect with respect to its papillary muscle, said method comprising:
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introducing a clamp transmurally into the beating heart and through the papillary muscle;
grasping a portion of the leaflet with said clamp;
piercing a hole in the leaflet;
inserting a suture, having a first end, through said clamp and through said hole, said first end being displaced through said clamp instrument to emerge from a proximal end of said clamp;
removing said clamp from the beating heart; and
securing said first end, and a second end, of said suture against an exterior wall of the beating heart. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A method for repairing the mitral valve of a heart wherein at least one leaflet has suffered a defect with respect to its papillary muscle, said method comprising:
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(a) introducing a clamp transmurally into the beating heart and through the papillary muscle;
(b) grasping a portion of the leaflet with said clamp;
(c) piercing a hole in the leaflet;
(d) inserting a suture, having a first end, through said clamp and through said hole, said first end being displaced through said clamp to emerge from a proximal end of said clamp;
(e) maintaining a second end of said suture external to the beating heart;
(f) removing said clamp from the beating heart;
(g) repeating steps (a)-(f) to establish a plurality of first ends that emerge from a proximal end of said clamp and a plurality of second ends that are maintained external to beating heart; and
(h) securing said plurality of first ends and said plurality of second ends against an exterior wall of the beating heart.
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18. An apparatus for repairing the mitral valve of a heart wherein at least one leaflet has suffered a defect with respect to its papillary muscle, said apparatus comprising:
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a clamp comprising first and second elongated members having respective first and second distal ends for clamping the leaflet;
an external cylinder in which said clamp is slidable;
a hollow piercing member, having a leading edge that can pierce tissue, that slides within said clamp;
a suture driver device that couples to one end of said hollow piercing member, and wherein movement of said external cylinder acts on said first and second members to open or close said clamp to grasp or release the leaflet, wherein said displacement of said hollow piercing member punctures said leaflet to form a hole therein and wherein said suture driver device drives a suture through said hollow piercing member for permitting said suture to pass through the leaflet and through said clamp for supporting mitral valve repair by connecting the leaflet to the papillary muscle. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32)
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33. An apparatus for stabilizing a portion of the heart wall of a beating heart to permit the transmural introduction of surgical instruments through the heart, said apparatus comprises a housing having:
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a first support surface that contacts the heart wall of the beating heart and provides a stable target for transmural penetration;
a central passageway for permitting coupling of an epivascular ultrasound probe, for the passage of instruments used for the Seldinger technique, and for the passage of an introducer therethrough; and
an extension formed with said first support surface for coupling to an externally fixed object.
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- 34. A suture driver device for driving a suture through a surgical device that has penetrated some portion of a living being and wherein the surgical device provides a path for delivery of the suture, said suture driver device comprising a syringe having a port that can couple to the surgical device, said syringe comprising a chamber filled with a biocompatible fluid and with said suture, said suture comprising a weighted end that is initially disposed at said port such that when said syringe is activated, said weighted end is driven through said surgical device.
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37. A suture driver device for driving a suture through a surgical device that has penetrated some portion of a living being and wherein the surgical device provides a path for delivery of the suture, said suture driver device comprising a syringe having:
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a first port that can couple to a proximal end of the surgical device;
a second port, in fluid communication with said first port;
a chamber in fluid communication with said first and second ports and filled with a biocompatible fluid; and
wherein, before said suture driver device is activated, said suture is passed through said first port and through said second port so that a first end of said suture is located externally of said suture driver device and a second weighted end of said suture is positioned at said first port. - View Dependent Claims (38)
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39. An apparatus for securing the free ends of a suture that have passed through an internal body part of a living being, said apparatus comprising:
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a ring having an inner surface with a plurality of channels, each of said channels comprising teeth;
a corresponding plug that fits snuggly within an opening of said ring;
wherein the free ends of the suture are passed through said opening in said ring and each one of said free ends are positioned in respective ones of said plurality of channels and wherein said plug is then positioned snuggly within said opening and wherein said ring and plug are positioned against said internal body part.
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40. A strain gauge device for detecting the tension applied to the free ends of a suture that has passed through the body part of a living being, said strain gauge device comprising a housing that can be coupled to the free ends of the suture, said housing comprising:
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a strain gauge or load cell for detecting the strain or load applied to the suture;
a display, coupled to said strain gauge or load cell, for displaying tension values;
a stepper motor, coupled to said display, for increasing or decreasing applied tension to the suture; and
control keys coupled to said display and to said stepper motor for permitting a user to control the tension applied to the suture.
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Specification