Permanently implantable system and method for detecting diagnosing and treating congestive heart failure
First Claim
1. Apparatus for treating congestive heart failure in a medical patient, the apparatus comprising:
- a pressure transducer operable to generate a signal indicative of fluid pressure within the left atrium;
signal processing apparatus operable to generate a signal indicative of an appropriate therapeutic treatment based at least in part on the signal generated by the pressure transducer;
a patient signaling device operable to communicate the signal indicative of the appropriate therapeutic treatment to the patient, wherein the patient signaling device is operable to generate at least two distinct signals distinguishable from one another by the patient, each said signal indicative of a different therapeutic treatment; and
an implantable flexible lead connected to the pressure transducer.
1 Assignment
0 Petitions
Accused Products
Abstract
The invention provides improved apparatus and methods for treating congestive heart failure in a medical patient. The apparatus includes a pressure transducer permanently implantable within the left atrium of the patient'"'"'s heart and operable to generate electrical signals indicative of fluid pressures within the patient'"'"'s left atrium. The pressure transducer is connected to a flexible electrical lead, which is connected in turn to electrical circuitry, which in the preferred embodiment includes digital circuitry for processing electrical signals. The electrical circuitry processes the electrical signals from the pressure transducer and, based at least in part on those signals, generates a signal that indicates a desired therapeutic treatment for treating the patient'"'"'s condition. That signal is then communicated to the patient via a patient signaling device, following which the patient administers to him or herself the prescribed therapeutic treatment indicated by the signal.
131 Citations
155 Claims
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1. Apparatus for treating congestive heart failure in a medical patient, the apparatus comprising:
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a pressure transducer operable to generate a signal indicative of fluid pressure within the left atrium;
signal processing apparatus operable to generate a signal indicative of an appropriate therapeutic treatment based at least in part on the signal generated by the pressure transducer;
a patient signaling device operable to communicate the signal indicative of the appropriate therapeutic treatment to the patient, wherein the patient signaling device is operable to generate at least two distinct signals distinguishable from one another by the patient, each said signal indicative of a different therapeutic treatment; and
an implantable flexible lead connected to the pressure transducer. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33)
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34. Apparatus for treating congestive heart failure in a medical patient, the apparatus comprising:
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a pressure transducer operable to generate a signal indicative of fluid pressure within the left atrium;
signal processing apparatus operable to generate a signal indicative of an appropriate therapeutic treatment based at least in part on the signal generated by the pressure transducer;
a patient signaling device operable to communicate the signal indicative of the appropriate therapeutic treatment to the patient, wherein the patient signaling device is operable to generate at least two distinct signals distinguishable from one another by the patient, each said signal indicative of a different therapeutic treatment; and
apparatus operable to anchor the pressure transducer to the patient'"'"'s atrial septum. - View Dependent Claims (35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64)
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65. Apparatus for treating congestive heart failure in a medical patient, the apparatus comprising:
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a pressure transducer operable to generate a signal indicative of fluid pressure within the left atrium;
signal processing apparatus operable to generate a signal indicative of an appropriate therapeutic treatment based at least in part on the signal generated by the pressure transducer; and
a patient signaling device operable to communicate the signal indicative of the appropriate therapeutic treatment to the patient;
an implantable flexible lead connected to the pressure transducer; and
apparatus configured to anchor the pressure transducer to the patient'"'"'s atrial septum comprising a helical screw configured for advancement into and fixation within the atrial septum.
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66. Apparatus for treating congestive heart failure in a medical patient, the apparatus comprising:
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a pressure transducer operable to generate a signal indicative of fluid pressure within the left atrium;
signal processing apparatus operable to generate a signal indicative of an appropriate therapeutic treatment based at least in part on the signal generated by the pressure transducer;
a patient signaling device operable to communicate the signal indicative of the appropriate therapeutic treatment to the patient;
an implantable flexible lead connected to the pressure transducer; and
apparatus configured to anchor the pressure transducer to the patient'"'"'s atrial septum comprising at least one anchor deployable by spring force upon the withdrawal of a removable sheath to expose the anchor.
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67. Apparatus for treating congestive heart failure in a medical patient, the apparatus comprising:
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a pressure transducer operable to generate a signal indicative of fluid pressure within the left atrium;
signal processing apparatus operable to generate a signal indicative of an appropriate therapeutic treatment based at least in part on the signal generated by the pressure transducer;
a patient signaling device operable to communicate the signal indicative of the appropriate therapeutic treatment to the patient;
an implantable flexible lead connected to pressure transducer, wherein the pressure transducer is located on the lead a predetermined distance away from a distal tip of the lead, wherein the distance is predetermined so that the pressure transducer will be positioned within the patient'"'"'s left atrium when the distal tip is positioned within a pulmonary vein connected to the patient'"'"'s left atrium.
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68. Apparatus for treating congestive heart failure in a medical patient, the apparatus comprising:
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a pressure transducer operable to generate a signal indicative of fluid pressure within the left atrium;
signal processing apparatus operable to generate a signal indicative of an appropriate therapeutic treatment based at least in part on the signal generated by the pressure transducer;
a patient signaling device operable to communicate the signal indicative of the appropriate therapeutic treatment to the patient;
an implantable flexible lead connected to pressure transducer, wherein the lead comprises a first lead component carrying apparatus configured to anchor the first lead component to the patient'"'"'s atrial septum and a second lead component carrying the pressure transducer, wherein the second lead component is implantable into the patient and fixable to the first lead component after the first lead component is implanted within the patient.
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69. Apparatus for treating congestive heart failure in a medical patient, the apparatus comprising:
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a pressure transducer operable to generate a signal indicative of fluid pressure within the left atrium;
signal processing apparatus operable to generate a signal indicative of an appropriate therapeutic treatment based at least in part on the signal generated by the pressure transducer;
a patient signaling device operable to communicate the signal indicative of the appropriate therapeutic treatment to the patient; and
a second sensor in addition to the pressure transducer, the second sensor operable to generate a second signal indicative of a second condition within the body of the patient, wherein the signal processing apparatus is operable to generate a signal indicative of an appropriate therapeutic treatment based at least in part on the second signal generated by the second sensor. - View Dependent Claims (70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 102, 103)
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80. A method for treating congestive heart failure in a medical patient, the method comprising:
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implanting a pressure transducer within the medical patient;
operating the pressure transducer to generate a signal indicative of fluid pressure within the left atrium;
communicating the signal indicative of the fluid pressure within the left atrium to signal processing apparatus;
operating the signal processing apparatus to generate a signal indicative of an appropriate therapeutic treatment, wherein operating the signal processing apparatus includes generating one of at least two distinct signals, each said signal indicative of a different therapeutic treatment; and
communicating the signal indicative of the appropriate therapeutic treatment to the patient. - View Dependent Claims (81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 104, 105, 106, 107, 108)
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109. A method for treating congestive heart failure in a medical patient, the method comprising:
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implanting a pressure transducer within the medical patient, wherein implanting the pressure transducer within the medical patient comprises;
approaching the left atrium through the right atrium;
penetrating the patient'"'"'s atrial septum; and
positioning the pressure transducer in pressure sensing contact with the patient'"'"'s left atrium;
operating the pressure transducer to generate a signal indicative of fluid pressure within the left atrium;
communicating the signal indicative of the fluid pressure within the left atrium to signal processing apparatus;
operating the signal processing apparatus to generate a signal indicative of an appropriate therapeutic treatment; and
communicating the signal indicative of the appropriate therapeutic treatment to the patient. - View Dependent Claims (110, 111)
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112. A method for treating congestive heart failure in a medical patient, the method comprising:
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implanting a pressure transducer within the medical patient;
operating the pressure transducer to generate a signal indicative of fluid pressure within the left atrium;
communicating the signal indicative of the fluid pressure within the left atrium to signal processing apparatus;
operating the signal processing apparatus to generate a signal indicative of an appropriate therapeutic treatment;
communicating the signal indicative of the appropriate therapeutic treatment to the patient; and
anchoring the pressure transducer to the patient'"'"'s atrial septum, by advancing a helical screw into the patient'"'"'s atrial septum.
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113. A method for treating congestive heart failure in a medical patient, the method comprising:
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implanting a pressure transducer substantially permanently within the left atrium of the patient'"'"'s heart, wherein said implanting includes advancing a flexible lead carrying the pressure transducer partially into a pulmonary vein connected to the left atrium while positioning the pressure transducer within the left atrium;
operating the pressure transducer to generate a signal indicative of fluid pressure within the left atrium;
communicating the signal indicative of the fluid pressure within the left atrium to signal processing apparatus;
operating the signal processing apparatus to generate a signal indicative of an appropriate therapeutic treatment; and
communicating the signal indicative of the appropriate therapeutic treatment to the patient.
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114. A method for treating congestive heart failure in a medical patient, the method comprising:
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implanting a pressure transducer within the medical patient, wherein said implanting comprises;
advancing a first lead component carrying anchoring apparatus to the left atrium and deploying the anchoring apparatus to anchor the first lead component to the patient'"'"'s atrial septum; and
advancing a second lead component carrying a pressure transducer along the first lead component until the second lead component is in a position wherein the pressure transducer is positioned in pressure sensing contact with the patient'"'"'s left atrium;
operating the pressure transducer to generate a signal indicative of fluid pressure within the left atrium;
communicating the signal indicative of the fluid pressure within the left atrium to signal processing apparatus;
operating the signal processing apparatus to generate a signal indicative of an appropriate therapeutic treatment; and
communicating the signal indicative of the appropriate therapeutic treatment to the patient. - View Dependent Claims (115, 116, 117, 118, 119)
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120. A method for treating congestive heart failure in a medical patient, the method comprising:
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implanting a pressure transducer within the medical patient;
operating the pressure transducer to generate a signal indicative of fluid pressure within the left atrium;
communicating the signal indicative of the fluid pressure within the left atrium to signal processing apparatus;
operating the signal processing apparatus to generate a signal indicative of an appropriate therapeutic treatment; and
communicating the signal indicative of the appropriate therapeutic treatment to the patient, wherein said communicating includes operating a mechanical vibrator to produce a vibration perceptible by the patient. - View Dependent Claims (121, 122, 123, 124, 125)
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126. A method for treating congestive heart failure in a medical patient, the method comprising:
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implanting a pressure transducer within the medical patient;
operating the pressure transducer to generate a signal indicative of fluid pressure within the left atrium;
communicating the signal indicative of the fluid pressure within the left atrium to signal processing apparatus;
operating the signal processing apparatus to generate a signal indicative of an appropriate therapeutic treatment; and
communicating the signal indicative of the appropriate therapeutic treatment to the patient, wherein said communicating includes operating a transmitter to send information to a remote receiver. - View Dependent Claims (127, 128, 129, 130, 131)
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132. A method for treating congestive heart failure in a medical patient, the method comprising:
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implanting a pressure transducer within the medical patient;
operating the pressure transducer to generate a signal indicative of fluid pressure within the left atrium;
communicating the signal indicative of the fluid pressure within the left atrium to signal processing apparatus;
operating the signal processing apparatus to generate a signal indicative of an appropriate therapeutic treatment;
communicating the signal indicative of the appropriate therapeutic treatment to the patient; and
operating power management circuitry to deny power to at least some portions of the signal processing apparatus during periods of relative inactivity between periods of active operation of those portions of the signal processing apparatus. - View Dependent Claims (133, 134, 135, 136, 137)
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138. A method for treating congestive heart failure in a medical patient, the method comprising:
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implanting a pressure transducer within the medical patient operating the pressure transducer to generate a signal indicative of fluid pressure within the left atrium;
communicating the signal indicative of the fluid pressure within the left atrium to signal processing apparatus;
operating the signal processing apparatus to generate a signal indicative of an appropriate therapeutic treatment, wherein said operating includes computing mean left atrial pressures based on multiple individual signals generated by the pressure transducer; and
communicating the signal indicative of the appropriate therapeutic treatment to the patient. - View Dependent Claims (139, 140, 141, 142, 143)
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144. A method for treating congestive heart failure in a medical patient, the method comprising:
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implanting a pressure transducer within the medical patient;
operating the pressure transducer to generate a signal indicative of fluid pressure within the left atrium;
communicating the signal indicative of the fluid pressure within the left atrium to signal processing apparatus;
operating the signal processing apparatus to generate a signal indicative of an appropriate therapeutic treatment, wherein said operating includes generating a signal indicative of an appropriate therapeutic treatment comprising a reduction in the normal dose of at least one medication taken by the patient; and
communicating the signal indicative of the appropriate therapeutic treatment to the patient. - View Dependent Claims (145, 146, 147, 148, 149)
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150. A method for treating congestive heart failure in a medical patient, the method comprising:
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implanting a pressure transducer within the medical patient;
operating the pressure transducer to generate a signal indicative of fluid pressure within the left atrium;
communicating the signal indicative of the fluid pressure within the left atrium to signal processing apparatus;
operating the signal processing apparatus to generate a signal indicative of an appropriate therapeutic treatment; and
communicating the signal indicative of the appropriate therapeutic treatment to the patient, wherein communicating the signal includes communicating to the patient at least one predetermined sequence comprising multiple individual signal pulses perceptible by the patient.
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151. A method for treating congestive heart failure in a medical patient, the method comprising:
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implanting a pressure transducer within the medical patient;
operating the pressure transducer to generate a signal indicative of fluid pressure within the left atrium;
communicating the signal indicative of the fluid pressure within the left atrium to signal processing apparatus;
operating the signal processing apparatus to generate a signal indicative of an appropriate therapeutic treatment, wherein operating the signal processing apparatus includes diagnosing a cause of worsening CHF; and
communicating the signal indicative of the appropriate therapeutic treatment to the patient.
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152. Apparatus for treating congestive heart failure in a medical patient, the apparatus comprising:
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indicator means for generating a signal indicative of fluid pressure within the left atrium;
signal processing apparatus operable to generate a signal indicative of an appropriate therapeutic treatment based at least in part on the signal generated by the indicator means; and
a patient signaling device operable to communicate the signal indicative of the appropriate therapeutic treatment to the patient; and
apparatus configured to anchor the indicator means to the patient'"'"'s atrial septum, wherein the apparatus comprises a helical screw configured for advancement into and fixation within the atrial septum.
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153. Apparatus for treating congestive heart failure in a medical patient, the apparatus comprising:
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indicator means for generating a signal indicative of fluid pressure within the left atrium;
signal processing apparatus operable to generate a signal indicative of an appropriate therapeutic treatment based at least in part on the signal generated by the indicator means; and
a patient signaling device operable to communicate the signal indicative of the appropriate therapeutic treatment to the patient; and
apparatus configured to anchor the indicator means to the patient'"'"'s atrial septum, wherein the apparatus comprises at least one anchor deployable by spring force upon the withdrawal of a removable sheath to expose the anchor.
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154. Apparatus for treating congestive heart failure in a medical patient, the apparatus comprising:
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indicator means for generating a signal indicative of fluid pressure within the left atrium, wherein the indicator means is located on the lead a predetermined distance away from a distal tip of the lead, wherein the distance is predetermined so that the indicator means will be positioned within the patient'"'"'s left atrium when the distal tip is positioned within a pulmonary vein connected to the patient'"'"'s left atrium;
signal processing apparatus operable to generate a signal indicative of an appropriate therapeutic treatment based at least in part on the signal generated by the indicator means; and
a patient signaling device operable to communicate the signal indicative of the appropriate therapeutic treatment to the patient;
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155. Apparatus for treating congestive heart failure in a medical patient, the apparatus comprising:
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indicator means for generating a signal indicative of fluid pressure within the left atrium;
signal processing apparatus operable to generate a signal indicative of an appropriate therapeutic treatment based at least in part on the signal generated by the indicator means; and
a patient signaling device operable to communicate the signal indicative of the appropriate therapeutic treatment to the patient; and
an implantable flexible lead connected to the indicator means, wherein the lead comprises a first lead component carrying apparatus configured to anchor the first lead component to the patient'"'"'s atrial septum and a second lead component carrying the indicator means, wherein the second lead component is implantable into the patient and fixable to the first lead component after the first lead component is implanted within the patient.
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Specification