DEVICES, SYSTEMS AND METHODS FOR EPICARDIAL CARDIAC MONITORING SYSTEM
First Claim
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1. A portable monitoring system for monitoring the physiology of a heart, the portable monitoring system comprising:
- a memory device for storing data; and
a sensory lead coupled with the memory device by at least a first connecting wire, the sensory lead comprising;
a connection assembly, andat least one sensor for collecting physiologic data from an epicardial surface of a heart, the at least one sensor coupled with the connection assembly by a second connecting wire;
wherein the sensory lead is fully implantable within the chest cavity of a patient, and the memory device is capable of receiving the physiologic data collected by the at least one sensor through the first connecting wire.
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Accused Products
Abstract
Devices, systems, and methods for remotely monitoring physiologic cardiovascular data are disclosed. At least some of the embodiments disclosed herein provide access to the external surface of the heart through the pericardial space for the delivery of the sensor to the epicardial surface of the heart. In addition, various disclosed embodiments provide for a memory device capable of receiving the physiologic cardiovascular data collected by the sensors and transmitting such data wirelessly to a remote location.
133 Citations
58 Claims
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1. A portable monitoring system for monitoring the physiology of a heart, the portable monitoring system comprising:
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a memory device for storing data; and a sensory lead coupled with the memory device by at least a first connecting wire, the sensory lead comprising; a connection assembly, and at least one sensor for collecting physiologic data from an epicardial surface of a heart, the at least one sensor coupled with the connection assembly by a second connecting wire; wherein the sensory lead is fully implantable within the chest cavity of a patient, and the memory device is capable of receiving the physiologic data collected by the at least one sensor through the first connecting wire. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
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20. A sensor assembly for collecting physiologic data from a targeted tissue, the sensory assembly comprising:
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a scaffold assembly having a body comprising a top portion, a bottom portion, and a first delivery channel, the bottom portion having a plurality openings therein and the first delivery channel in fluid communication with the plurality of openings in the bottom portion; a delivery catheter, the delivery catheter comprising a proximal end, a distal end, and first and second lumens extending between the proximal end and the distal end;
the first lumen comprising a second delivery channel in fluid communication with the first delivery channel of the scaffold assembly, and the second lumen comprising a wire channel in communication with the bottom portion of the scaffold assembly;at least one sensor capable of collecting physiologic data from a targeted tissue, the at least one sensor coupled within the body of the scaffold assembly; and a connecting wire for transferring physiologic data collected by the at least one sensor, the connecting wire comprising a distal end coupled with the at least one sensor and a proximal end encased within the wire channel of the delivery catheter; wherein the first delivery channel of the scaffold assembly, the second delivery channel of the delivery catheter, and the number of openings in the bottom portion of the scaffold assembly are capable of allowing an adhesive substance to flow therethrough and onto the targeted tissue. - View Dependent Claims (21, 22, 23, 24, 25)
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26. A method for attaching a sensory assembly to a surface of a targeted tissue comprising the steps of:
providing a sensor assembly comprising; a scaffold assembly having a body comprising a top portion, a bottom portion, and a first delivery channel, the bottom portion having a plurality openings therein and the first delivery channel in fluid communication with the plurality of openings in the bottom portion, a delivery catheter, the delivery catheter comprising a proximal end, a distal end, and first and second lumens extending between the proximal end and the distal end;
the first lumen comprising a second delivery channel in fluid communication with the first delivery channel of the scaffold assembly, and the second lumen comprising a wire channel in communication with the bottom portion of the scaffold assembly,at least one sensor capable of collecting physiologic data from a targeted tissue, the at least one sensor coupled within the body of the scaffold assembly, and a connecting wire for transferring physiologic data collected from the at least one sensor, the connecting wire comprising a distal end coupled with the at least one sensor and a proximal end encased within the wire channel of the delivery catheter, wherein the first delivery channel of the scaffold assembly, the second delivery channel of the delivery catheter, and the number of openings in the bottom portion of the scaffold assembly are capable of allowing an adhesive substance to flow therethrough and onto the targeted tissue; positioning the at least one sensor of the sensor assembly on a targeted tissue surface; inserting an adhesive into the second delivery channel of the delivery catheter; and applying the adhesive to the targeted tissue surface by advancing the adhesive through the second delivery channel of the delivery catheter, the first delivery channel of the scaffold assembly, and through the plurality of openings in the bottom portion of the scaffold assembly; and allowing the adhesive to adhere to the targeted tissue surface and the bottom portion of the scaffold assembly. - View Dependent Claims (27, 28)
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29. A sensor assembly for collecting physiologic data from a targeted tissue, the sensory assembly comprising:
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a capsula having an exterior wall and a disk, the exterior wall comprising a flexible material and defining a closed end, an open end, and an interior space and the disk coupled with the closed end of the exterior wall; a vacuum catheter having a proximal end and a distal end, the distal end of the vacuum catheter coupled with the exterior wall of the capsula and in communication with the interior space of the capsula; at least one sensor capable of collecting physiologic data from a targeted tissue, the at least one sensor removably coupled with the disk of the capsula such that the at least one sensor extends into the interior space of the capsula; wherein the open end of the capsula is configured to removably attach to a targeted tissue such that the application of suction to the vacuum catheter is capable of forming a reversible seal with the targeted tissue. - View Dependent Claims (30, 31, 32, 33)
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34. A method for attaching a sensory assembly to a surface of a targeted tissue comprising the steps of:
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providing a sensor assembly comprising; a capsula having an exterior wall and a disk, the exterior wall comprising a flexible material and defining a closed end, an open end, and an interior space and the disk coupled with the closed end of the exterior wall, a vacuum catheter having a proximal end and a distal end, the distal end of the vacuum catheter coupled with the exterior wall of the capsula and in communication with the interior space of the capsula, and at least one sensor capable of collecting physiologic data from a targeted tissue, the at least one sensor removably coupled with the disk of the capsula such that the at least one sensor extends into the interior space of the capsula, wherein the open end of the capsula is configured to removably attach to a targeted tissue such that the application of suction to the vacuum catheter is capable of forming a reversible seal with the targeted tissue, and the exterior wall of the capsula is capable of shifting from a first upright position to a second collapsed position when suction is applied to the vacuum catheter; positioning the sensor assembly proximate to a targeted tissue surface; coupling the open end of the capsula with the targeted tissue surface by applying a suctional force to the proximal end of the vacuum catheter; coupling the at least one sensor with the surface of the targeted tissue surface by shifting the exterior wall of the capsula to the second collapsed position; ceasing the suctional force through the vacuum catheter; uncoupling the at least one sensor from the disk of the capsula; and withdrawing the sensor assembly. - View Dependent Claims (35, 36, 37, 38, 39, 40)
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41. A sensor assembly for collecting physiologic data from a targeted tissue, the sensory assembly comprising:
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a capsula having an exterior wall, a disk, and a flexible membrane, the exterior wall defining a closed end, an open end, and an interior space, the disk coupled with the flexible membrane, and the flexible membrane extending through the interior space and defining an upper chamber between the flexible membrane and the closed end of the exterior wall and a lower chamber between the flexible membrane and the open end of the exterior wall; a vacuum catheter having a proximal end and a distal end, the distal end of the vacuum catheter coupled with the exterior wall of the capsula and in communication with the lower chamber of the capsula; a delivery catheter having a proximal end and a distal end, the distal end of the delivery catheter coupled with the exterior wall of the capsula and in communication with the upper chamber of the capsula; at least one sensor capable of collecting physiologic data from a targeted tissue, the at least one sensor removably coupled with the disk such that the at least one sensor extends into the lower chamber of the capsula; wherein the open end of the capsula is configured to removably attach to a targeted tissue such that the application of suction to the vacuum catheter is capable of forming a reversible seal with the targeted tissue, and the flexible membrane is capable of shifting from a first upright position to a second collapsed position when a gas is introduced into the upper chamber through the delivery catheter and suction is applied to the vacuum catheter. - View Dependent Claims (42, 43, 44, 45)
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46. A method for attaching a sensory assembly to a surface of a targeted tissue comprising the steps of:
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providing a sensor assembly comprising; a capsula having an exterior wall, a disk, and a flexible membrane, the exterior wall defining a closed end, an open end, and an interior space, the disk coupled with the flexible membrane, and the flexible membrane extending through the interior space and defining an upper chamber between the flexible membrane and the closed end of the exterior wall and a lower chamber between the flexible membrane and the open end of the exterior wall, a vacuum catheter having a proximal end and a distal end, the distal end of the vacuum catheter coupled with the exterior wall of the capsula and in communication with the lower chamber of the capsula, a delivery catheter having a proximal end and a distal end, the distal end of the delivery catheter coupled with the exterior wall of the capsula and in communication with the upper chamber of the capsula, at least one sensor capable of collecting physiologic data from a targeted tissue, the at least one sensor removably coupled with the disk such that the at least one sensor extends into the lower chamber of the capsula, wherein the open end of the capsula is configured to removably attach to a targeted tissue such that the application of suction to the vacuum catheter is capable of forming a reversible seal with the targeted tissue, and the flexible membrane is capable of shifting from a first upright position to a second collapsed position when a gas is introduced into the upper chamber through the delivery catheter and suction is applied to the vacuum catheter; positioning the sensor assembly proximate to a targeted tissue surface; coupling the open end of the capsula with the targeted tissue surface by applying a suctional force to the proximal end of the vacuum catheter; introducing a gas into the upper chamber of the capsula through the delivery catheter; coupling the at least one sensor with the surface of the targeted tissue surface by shifting the flexible membrane of the capsula to the second collapsed position; ceasing the suctional force through the vacuum catheter and the introduction of the gas through the delivery catheter; uncoupling the at least one sensor from the disk of the capsula; and withdrawing the sensor assembly. - View Dependent Claims (47, 48, 49, 50, 51, 52)
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53. A method of delivering a monitoring system to a heart, the method comprising the steps of:
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providing a system comprising; an engagement catheter comprising a proximal end, a distal end and first and second lumens extending between the proximal end and the distal end; a first delivery catheter comprising a proximal end, a distal end, and a hollow tube extending between the proximal end and the distal end, the first delivery catheter configured to be inserted into the second lumen of the engagement catheter; a needle located at the distal end of the first delivery catheter; and a vacuum port located at the proximal end of the engagement catheter, the vacuum port being operatively connected to the first lumen of the engagement catheter and capable of operative connection to the vacuum source; a second delivery catheter comprising a proximal end, a distal end, and a hollow tube extending between the proximal end and the distal end, the second delivery catheter configured to be inserted into the second lumen of the engagement catheter; a monitoring system comprising; a memory device for storing data, and a sensory lead coupled with the memory device by at least a first connecting wire and positioned within the distal end of the second delivery catheter, the sensory lead comprising; a connection assembly configured to traverse an opening in a wall of a heart, and at least one sensor for collecting physiologic data from an epicardial surface of a heart, the at least one sensor coupled with the connection assembly by a second connecting wire, wherein the sensory lead is fully implantable within the chest cavity of a patient, and the memory device is capable of receiving the physiologic data collected by the at least one sensor through the first connecting wire, wherein the first lumen of the engagement catheter includes a suction port located at or near the distal end of the engagement catheter, the suction port configured to removably attach to a targeted tissue on the interior of a wall of the heart, such that the suction port is capable of forming a reversible seal with the targeted tissue when the vacuum source is operatively attached to the vacuum port, and wherein the system is capable of enlarging a pericardial space between the targeted tissue and a pericardial sac that surrounds a heart by retracting the targeted tissue away from the pericardial sac; inserting the engagement catheter into the body such that the distal end of the engagement catheter is positioned inside the heart and the suction port is in contact with the targeted tissue on the interior of the wall of the heart; operatively connecting a vacuum source to the vacuum port such that the suction port is reversibly attached to the targeted tissue on the interior of the wall of the heart; inserting the first delivery catheter into the second lumen of the engagement catheter; piercing the targeted tissue on the interior of a wall of the heart with the needle, thereby forming an opening in the wall of the heart; accessing the pericardial space by inserting a guide wire through the wall of the heart into the pericardial space; withdrawing the first delivery catheter from the second lumen of the engagement catheter; inserting the second delivery catheter into the second lumen of the engagement catheter; advancing the distal end of the second delivery catheter into the pericardial space; delivering the at least one sensor of the sensory lead into the pericardial space and coupling the at least one sensor with an epicardial surface of the heart; withdrawing the second delivery catheter into the interior of the heart; delivering the connection assembly of the sensory lead into the opening in the wall of the heart, thereby sealing the opening; removing the second delivery catheter from the engagement catheter; and implanting the memory device under the skin of the body.
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- 54. The method of claim 54, wherein the targeted tissue comprises a portion of an atrial wall.
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56. A method of delivering a monitoring system to a heart, the method comprising the steps of:
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extending into a blood vessel an elongated tube having a proximal end, a distal end, and at least one lumen, such that the distal end of the tube is in contact with a targeted tissue on the interior of the wall of the heart; aspirating the targeted tissue such that the wall of the heart is retracted away from a pericardial sac surrounding the heart to enlarge a pericardial space between the pericardial sac and the wall of the heart; accessing the pericardial space by puncturing the wall of the heart; delivering at least one sensor to the pericardial space; coupling the at least one sensor to the epicardial surface of the heart; and removing the elongated tube from the body. - View Dependent Claims (57, 58)
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Specification