Mitral valve device using conditioned shape memory alloy
First Claim
1. A device adapted to be inserted into a coronary sinus within a body of a patient, for use in modifying an annulus of a mitral valve of the patient to treat a mitral valve pathology, comprising:
- (a) a structure having at least a portion thereof comprising a shape memory alloy, said shape memory alloy having a characteristic temperature, Af, selected to be no greater than a normal temperature of a body of a patient in which the device will be used, and having a programmed shape to which the shape memory alloy returns when substantially converted to an austenitic state; and
(b) a restraint that mechanically maintains the shape memory alloy in a deformed state while the structure is being inserted info a coronary sinus of a patient, said restraint being controlled to enable the shape memory alloy to return to its austenitic state, causing the shape memory alloy to try to assume its programmed shape with a coronary sinus, said programmed shape being selected and said structure being disposed at a desired orientation within a coronary sinus by the restraint so as to apply a force against a mitral valve to modify an annulus of the mitral valve.
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Accused Products
Abstract
A mitral valve annulus reshaping device includes at least a portion that is formed of a biocompatible shape memory alloy SMA having a characteristic temperature, Af, that is preferably below body temperature. The device is constrained in an unstable martensite (UM) state while being introduced through a catheter that passes through the venous system and into the coronary sinus of the heart. The reshaping device is deployed adjacent to the mitral valve annulus of the heart as it is forced from the catheter. When released from the constraint of the catheter, the SMA of the device at least partially converts from the UM state to an austenitic state and attempts to change to a programmed shape that exerts a force on the adjacent tissue and modifies the shape of the annulus. The strain of the SMA can be varied when the device is within the coronary sinus.
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Citations
77 Claims
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1. A device adapted to be inserted into a coronary sinus within a body of a patient, for use in modifying an annulus of a mitral valve of the patient to treat a mitral valve pathology, comprising:
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(a) a structure having at least a portion thereof comprising a shape memory alloy, said shape memory alloy having a characteristic temperature, Af, selected to be no greater than a normal temperature of a body of a patient in which the device will be used, and having a programmed shape to which the shape memory alloy returns when substantially converted to an austenitic state; and
(b) a restraint that mechanically maintains the shape memory alloy in a deformed state while the structure is being inserted info a coronary sinus of a patient, said restraint being controlled to enable the shape memory alloy to return to its austenitic state, causing the shape memory alloy to try to assume its programmed shape with a coronary sinus, said programmed shape being selected and said structure being disposed at a desired orientation within a coronary sinus by the restraint so as to apply a force against a mitral valve to modify an annulus of the mitral valve. - View Dependent Claims (2, 3, 4, 5, 6)
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7. A device adapted to be inserted into a coronary sinus within a body of a patient, for use in modifying an annulus of a mitral valve of the patient to treat a mitral valve pathology, comprising:
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(a) a venous deliverable component having at least a portion that is formed of a shape memory alloy, said shape memory alloy being selected to have a characteristic temperature, Af, that is no greater than a normal body temperature of a patient with which the device is used, said shape memory alloy being further characterized by being capable of reversibly changing between a martensite state and an austenitic state within a body of a patient, while remaining at substantially a constant temperature, said changes between the martensite state and austenitic state corresponding to a change in shape of the shape memory alloy; and
(b) at least a portion of the device comprising a selectively configurable force applying component to apply a force directed against an interior surface of a coronary sinus, causing a modification of an annulus of a mitral valve within a body of a patient. - View Dependent Claims (8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27)
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- 28. A device adapted to be inserted into a coronary sinus within a body of a patient, for use in modifying an annulus of a mitral valve of the patient to treat a mitral valve pathology, comprising a self-configuring assembly that is initially sized for delivery to a coronary sinus through a venous system of a patient, said self-configuring assembly at least in part comprising a shape memory alloy that is in a stressed martensite state when delivered to a coronary sinus and is selectively releasable to experience a lower stress, causing the shape memory alloy to self configure into a programmed shape, said self-configuring assembly changing shape at a temperature that is no greater than a body temperature of a patient with which the device is used, and upon being selectively released to a lower stress state, at least partially converting to an austenitic state to apply a force within a coronary sinus that enables a modification of an annulus of a mitral valve in a patient.
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44. A method for inserting a device adapted to modify an annulus of a mitral valve within a coronary sinus in a body of a patient, comprising the steps of:
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(a) constraining a self-configuring assembly to a size sufficiently small to advance through a venous system of the patient, at least a portion of said self-configuring assembly comprising a shape memory alloy having a characteristic temperature, Af, that is no greater than a normal body temperature of the patient;
(b) advancing the self-configuring assembly through the venous system and to a desired position within the coronary sinus; and
(c) selectively releasing the self-configuring assembly, enabling the self-configuring assembly to change shape as the shape memory alloy comprising the self-configuring assembly undergoes a change in state, a shape assumed by the self-configuring assembly facilitating the modification of the annulus of the mitral valve. - View Dependent Claims (45, 46, 47, 48, 49, 50, 51, 52)
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53. A method for inserting a mitral valve reshaping device for use in modifying an annulus of a mitral valve within a coronary sinus in a body of a patient, comprising the steps of:
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(a) constraining the mitral valve reshaping device to a size that enables said device to be advanced through a venous system of the patient, a least a portion of the mitral valve reshaping device comprising a stressed shape memory alloy that is in a martensite state at a normal body temperature of the patient;
(b) delivering the mitral valve reshaping device into coronary sinus of the patient through the venous system; and
(c) removing a constraint on the mitral valve reshaping device, enabling the shape memory alloy to at least partially change from the stressed martensite state of to an austenitic state as the stress on the shape memory alloy is reduced, so that the shape memory alloy tries to assume a programmed shape associated with the austenitic state, said programmed shape assisting in modifying the annulus of the mitral valve within the patient. - View Dependent Claims (54, 55, 56, 57, 58, 59, 60, 61, 62, 63)
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64. A method for inserting a device adapted to modify an annulus of a mitral valve within a coronary sinus in a body of a patient, comprising the steps of:
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(a) providing a shape memory alloy as at least a portion of the device, said shape memory alloy being capably of reversibly changing between a martensite state and an austenitic state at the normal body temperature of the patient and having a characteristic temperature, Af, that is no greater than the normal body temperature of the patient;
(b) constraining the shape memory alloy of the device in a martensite state;
(c) advancing the device through a venous system of the patient and into the coronary sinus, to a desired position;
(d) removing a constraint on the shape memory alloy so that it transforms from the martensite state to an austenitic state, transformation from the martensite state to the austenitic state enabling a change in shape of the shape memory alloy; and
(e) employing the change in shape of the shape memory alloy in modifying the annulus of the mitral valve. - View Dependent Claims (65, 66, 67, 68, 69, 70, 71)
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72. An assembly adapted for modifying an annulus of a mitral valve within a coronary sinus in a body of a patient, comprising:
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(a) a catheter sized so that a distal end of the catheter can be delivered into a coronary sinus through a venous system of a patient;
(b) a mitral valve reshaping device disposed within the catheter, at least a portion of said mitral valve reshaping device comprising a super-elastic shape memory metal having a characteristic temperature, Af, and being constrained within the catheter in a martensite state; and
(c) a pusher used to advance the mitral valve reshaping device through and toward the distal end of the catheter, to deploy the mitral valve reshaping device at a desired location within a coronary sinus of a patient, said super-elastic shape memory alloy then being permitted to change shape, to assist in modifying an annulus of a mitral valve. - View Dependent Claims (73, 74)
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75. An assembly adapted for modifying an annulus of a mitral valve within a coronary sinus in a body of a patient, comprising:
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(a) a catheter sized so that a distal end of the catheter can be delivered into a coronary sinus through a venous system of a patient;
(b) a cartridge coupled to the catheter;
(c) a mitral valve reshaping device disposed within the cartridge, at least a portion of said mitral valve reshaping device comprising a super-elastic shape memory metal having a characteristic temperature, Af, and being constrained within the cartridge in a martensite state; and
(d) a pusher used to advance the mitral valve reshaping device from the cartridge, while the mitral valve reshaping device remains constrained within the catheter, through and toward the distal end of the catheter, to deploy the mitral valve reshaping device at a desired location within a coronary sinus of a patient, said super-elastic shape memory alloy then being permitted to change shape, to assist in modifying an annulus of a mitral valve. - View Dependent Claims (76, 77)
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Specification