SYSTEMS AND METHODS FOR WIRELESS TREATMENT OF ARRHYTHMIAS
20190224476 ยท 2019-07-25
Assignee
- William Marsh Rice University (Houston, TX)
- Texas Heart Institute (Houston, TX, US)
- Baylor College Of Medicine (Houston, TX)
Inventors
- Yuxiang Sun (Houston, TX, US)
- Aydin Babakhani (Houston, TX, US)
- Mehdi Razavi (Houston, TX, US)
- DAVID BURKLAND (Houston, TX, US)
- BRIAN GREET (Houston, TX, US)
- MATHEWS JOHN (Houston, TX, US)
- Hongming Lyu (Houston, TX, US)
Cpc classification
A61N1/025
HUMAN NECESSITIES
A61N1/37288
HUMAN NECESSITIES
A61N1/0563
HUMAN NECESSITIES
A61N1/37229
HUMAN NECESSITIES
A61N1/0573
HUMAN NECESSITIES
A61N1/37217
HUMAN NECESSITIES
International classification
A61N1/05
HUMAN NECESSITIES
A61N1/372
HUMAN NECESSITIES
Abstract
Wireless treatment of arrhythmias. At least some of the example embodiments are methods including: charging a capacitor of a first microchip device abutting heart tissue, the charging by harvesting ambient energy; charging a capacitor of a second microchip device abutting the heart tissue, the charging of the capacitor of the second microchip device by harvesting ambient energy; sending a command wirelessly from a communication device outside the rib cage to the microchip devices; applying electrical energy to the heart tissue by the first microchip device responsive to the command, the electrical energy applied from the capacitor of the first microchip device; and applying electrical energy to the heart tissue by the second microchip device responsive to the command to the second microchip device, the electrical energy applied from the capacitor of the second microchip device.
Claims
1. An implantable medical device for applying electrical energy to heart tissue comprising: a substrate of semiconductor material; an anchoring structure mechanically coupled to the substrate; a capacitor associated with the substrate; an energy harvesting circuit defined on the substrate and electrically coupled to the capacitor, the energy harvesting circuit configured to extract electrical energy from energy propagating proximate the device and to store electrical energy on the capacitor; a communication circuit defined on the substrate, the communication circuit electrically coupled to the energy harvesting circuit, the communication circuit configured to receive commands originated external to the implantable medical device; an energy delivery circuit defined on the substrate, the energy delivery circuit electrically coupled to a set of electrodes, electrically coupled to the energy harvesting circuit, and communicatively coupled to the communication circuit; and the energy delivery circuit configured to provide electrical energy to the heart tissue across the set of electrodes responsive to the commands received by the communication circuit.
2. The implantable medical device of claim 1 wherein the communication circuit further comprises: a communication antenna defined on the substrate, the communication antenna operates at a frequency above 1 Mega Hertz (MHz); and the communication circuit configured to receive commands from an external device by way of the communication antenna.
3. The implantable medical device of claim 1 wherein the energy harvesting circuit further comprises: an energy harvesting antenna defined on the substrate, the energy harvesting antenna has an operating frequency above 1 Mega Hertz (MHz); a rectifier defined on the substrate, the rectifier electrically coupled between the energy harvesting antenna and the capacitor, the rectifier configured to rectify alternating current energy from the energy harvesting antenna to create rectified energy stored on the capacitor; and a power management unit defined on the substrate, the power management unit coupled to the capacitor, the power management unit configured to produce a regulated direct current (DC) voltage from rectified energy stored on the capacitor.
4. The implantable medical device of claim 1 wherein the energy harvesting circuit further comprises: a set of conductive pads; a rectifier defined on the substrate, the rectifier electrically coupled between the second set of conductive pads and the capacitor, the rectifier circuit configured to rectify alternating current energy flowing through the second set of conductive pads to create rectified energy stored on the capacitor; and a power management unit defined on the substrate, the power management unit coupled to the capacitor, the power management unit configured to produce a regulated DC voltage from the rectified energy stored on the capacitor.
5. The implantable medical device of claim 1 wherein the capacitor is at least one selected from a group comprising: a capacitor defined on the substrate; a capacitor mechanically coupled to the substrate; and a capacitor mechanically coupled to the anchoring structure.
6. The implantable medical device of claim 1 further comprising: a sensing circuit defined on the substrate, the sensing circuit electrically coupled to the energy harvesting circuit and communicatively coupled to the communication circuit; the sensing circuit configured to sense electrical impulses propagating through heart tissue, and configured to trigger the communication circuit to send a message responsive to the electrical impulses propagating through the heart tissue.
7. The implantable medical device of claim 6 wherein the sensing circuit further comprises: a set of conductive pads; and the sensing circuit configured to sense electrical impulses propagating through heart tissue by detecting at least one selected from a group comprising: electrical current flow through the set of conductive pads; and voltage across the set of conductive pads.
8.-9. (canceled)
10. The implantable medical device of claim 1 further comprising a structure to mechanically couple the anchoring structure to heart tissue comprising at least one selected from a group comprising: a means for mechanically coupling anchoring structure to the heart tissue: a helical screw mechanically coupled to the anchoring structure opposite the substrate; a pin that defines a distal end with a barb defined thereon, the pin mechanically coupled to the anchoring structure; and a plurality of pins that each define a distal end with a barb thereon, the pins mechanically coupled to the anchoring structure; a helical screw mechanically coupled to the anchoring structure opposite the substrate and electrically coupled to an electrode of the set of electrodes; a pin that defines a distal end with a barb defined thereon, the pin mechanically coupled to the anchoring structure and electrically coupled to an electrode of the set of electrodes; and a plurality of pins that each define a distal end with a barb thereon, the pins mechanically coupled to the anchoring structure, and each pin electrically coupled to a respective electrode of the set of electrodes.
11. A sensing device for detecting electrical impulses propagating through heart tissue, comprising: a substrate of semiconductor material; an anchoring structure mechanically coupled to the substrate; a capacitor associated with the substrate; an energy harvesting circuit defined on the substrate and electrically coupled to the capacitor, the energy harvesting circuit configured to extract electrical energy from energy propagating proximate the sensing device and to store electrical energy on the capacitor; a communication circuit defined on the substrate, the communication circuit electrically coupled to the energy harvesting circuit, the communication circuit configured to receive commands originated external to the sensing device; a sensing circuit defined on the substrate, the sensing circuit electrically coupled to the energy harvesting circuit and communicatively coupled to the communication circuit; and the sensing circuit configured to sense electrical impulses propagating through the heart tissue, and configured to trigger the communication circuit to send a message responsive to the electrical impulses propagating through the heart tissue.
12. The sensing device of claim 11 wherein the sensing circuit further comprises: a set of sensing conductive pads, the sensing circuit electrically coupled to the set of sensing conductive pads; and the sensing circuit configured to sense the electrical impulses propagating through heart tissue by detecting at least one selected from a group comprising: electrical current flow through the set of sensing electrodes; and voltage across the set of sensing conductive pads.
13. (canceled)
14. The sensing device of claim 11 wherein the energy harvesting circuit further comprises: an energy harvesting antenna defined on the substrate, the energy harvesting antenna has an operating frequency above 1 Mega Hertz (MHz); a rectifier defined on the substrate, the rectifier electrically coupled between the energy harvesting antenna and the capacitor, the rectifier configured to rectify alternating current energy from the energy harvesting antenna to create rectified energy stored on the capacitor; and a power management unit defined on the substrate, the power management unit coupled to the capacitor, the power management unit configured to produce a regulated DC voltage from the rectified energy stored on the capacitor.
15. The sensing device of claim 11 wherein the energy harvesting circuit further comprises: a set of conductive pads; a rectifier defined on the substrate, the rectifier electrically coupled between the second set of conductive pads and the capacitor, the rectifier configured to rectify alternating current energy flowing through the second set of conductive pads to create rectified energy stored on the capacitor; and a power management unit defined on the substrate, the power management unit coupled to the capacitor, the power management unit configured to produce a regulated DC voltage from rectified energy stored on the capacitor.
16. The sensing device of claim 11 wherein the capacitor is at least one selected from a group comprising: the capacitor is defined on the substrate; the capacitor is mechanically coupled to the substrate; and the capacitor is mechanically coupled to the anchoring structure.
17. (canceled)
18. The sensing device of claim 11 further comprising a structure to mechanically couple the anchoring structure to the heart tissue including at least one selected from a group comprising: a means for mechanically coupling the anchoring structure to the heart tissue: a helical screw mechanically coupled to the anchoring structure opposite the substrate; a pin that defines a distal end with a barb defined thereon, the pin mechanically coupled to the anchoring structure; and a plurality of pins that each define a distal end with a barb thereon, the pins mechanically coupled to the anchoring structure.
19. A system for treating arrhythmias in heart tissue comprising: a plurality of microchip devices without batteries, each microchip device comprising: a substrate of semiconductor material; a capacitor associated with the substrate; an energy harvesting circuit defined on the substrate and electrically coupled to the capacitor, the energy harvesting circuit configured to extract electrical energy from energy propagating proximate the microchip device and to store electrical energy on the capacitor; a communication circuit defined on the substrate, the communication circuit electrically coupled to the energy harvesting circuit, the communication circuit configured to receive commands originated external to the microchip device; an energy delivery circuit defined on the substrate, the energy delivery circuit electrically coupled to a set of electrodes, electrically coupled to the energy harvesting circuit, and communicatively coupled to the communication circuit; and the energy delivery circuit configured to provide electrical energy to heart tissue across the set of electrodes responsive to the commands received by the communication circuit; each microchip device mechanically coupled to the heart tissue, and the set of electrodes of each microchip device electrically coupled to the heart tissue; a communication device distinct from the plurality of microchip devices, the communication device communicatively coupled to the communication device of each of the plurality of microchip devices; and the plurality of microchip devices configured to apply electrical energy to the heart tissue responsive to commands from the communication device.
20. The system of claim 19 wherein the communication device is configured to defibrillate the heart tissue by a command to the plurality of microchip devices to substantially simultaneously apply electrical energy.
21. The system of claim 19 wherein the communication device is configured to pace the heart tissue by a command to the plurality of microchip devices to apply electrical energy sequentially along a predefined path, the predefined path intersects the plurality of microchip devices.
22. The system of claim 19 wherein the communication device is at least one selected from the group comprising: subcutaneously disposed; and external to a body containing the heart.
23. The system of claim 19 further comprising: the communication device comprises an antenna, and the communication device is configured to transmit electromagnetic waves toward the microchip devices; and the energy harvesting circuit of the microchip device is configured to extract the energy from the electromagnetic waves transmitted by the communication device.
24. The system of claim 19 wherein the energy harvesting circuit of the microchip device is configured to harvest energy from electrical impulses in the heart tissue.
25. The system of claim 19 further comprising: the communication device comprises a set of conductive pads electrically coupled to the body, and the communication device is configured to induce electrical current flow proximate to the plurality of microchip devices; and the energy harvesting circuit of the microchip device is configured to extract the energy from the electrical current flow.
26. A method of treating arrhythmias in heart tissue comprising: charging a capacitor of a first microchip device abutting the heart tissue, the charging by harvesting ambient energy by the first microchip device; charging a capacitor of a second microchip device abutting the heart tissue, the charging of the capacitor of the second microchip device by harvesting ambient energy by the second microchip device, and the second microchip spaced apart from the first microchip device; sending a command wirelessly from a communication device outside the rib cage to the first microchip device; sending a command wirelessly from the communication device to the second microchip device; applying electrical energy to the heart tissue by the first microchip device responsive to the command to the first microchip device, the electrical energy applied from the capacitor of the first microchip device; and applying electrical energy to the heart tissue by the second microchip device responsive to the command to the second microchip device, the electrical energy applied from the capacitor of the second microchip device.
27. The method of claim 26 further comprising defibrillating the heart tissue by simultaneously applying electrical energy by the first microchip device and the second microchip device.
28. The method of claim 26 further comprising pacing the heart tissue by sequentially applying electrical energy by the first microchip device and the second microchip device.
29. The method of claim 26 further comprising: sensing electrical impulses sourced by and propagating through the heart tissue, the sensing by the first microchip device; sending an indication of the electrical signal from the first microchip device to the communication device, the sending wirelessly; and sending the commands by the communication device responsive to the indication of the electrical impulse from the first microchip device.
30. The method of claim 26 further comprising: charging a capacitor of a third microchip device, the third microchip device distinct from the first and second microchip devices, the third microchip device abutting the heart tissue at a spaced apart location from the first and second microchip devices, and the charging by harvesting ambient energy by the third microchip device; sensing electrical impulses sourced by and propagating through the heart tissue, the sensing by the third microchip device; sending an indication of the electrical impulse from the third microchip device to the communication device, the sending wirelessly; and sending the commands by the communication device responsive to the indication of the electrical signal from the third microchip device.
31. The method of claim 26 wherein charging the first capacitor further comprises harvesting electrical energy from electromagnetic waves sourced by the communication device.
32. (canceled)
33. The method of claim 26 wherein charging the first capacitor further comprises harvesting electrical energy from electrical impulses sourced by and propagating through the heart tissue.
34. A system of microchip devices for implantation abutting heart tissue comprising: a carrier structure that defines a length; a plurality of microchip devices mechanically coupled to the carrier structure at spaced apart locations along the carrier structure; each microchip device further comprises: a substrate of semiconductor material; a capacitor associated with the substrate; an energy harvesting circuit defined on the substrate and electrically coupled to the capacitor, the energy harvesting circuit configured to extract electrical energy from energy propagating proximate the microchip device and to store electrical energy on the capacitor; a communication circuit defined on the substrate, the communication circuit electrically coupled to the energy harvesting circuit, the communication circuit configured to receive commands originated external to the microchip device; an energy delivery circuit defined on the substrate, the energy delivery circuit electrically coupled to a set of electrodes, electrically coupled to the energy harvesting circuit, and communicatively coupled to the communication circuit; and the energy delivery circuit configured to provide electrical energy to heart tissue across the set of electrodes responsive to the commands received by the communication circuit.
35. The system of claim 34 wherein the carrier structure is a metallic wire and the plurality of microchip devices are mechanically coupled to the metallic wire at spaced apart locations along a longitudinal axis of the wire.
36. The system of claim 34 wherein the carrier structure is a stent of metallic material, and the plurality of microchip devices are mechanically coupled to the stent at spaced apart locations along a longitudinal axis of the stent.
37. The system of claim 36 wherein the plurality of microchip devices are also spaced around the stent at distinct radial locations relative to the longitudinal axis of the stent.
38. The system of claim 34 wherein the carrier structure is a metal wire that defines a helix, and wherein the plurality of microchip devices are mechanically coupled to the metallic wire at spaced apart locations along the helix.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0049] For a detailed description of example embodiments, reference will now be made to the accompanying drawings (not necessarily to scale) in which:
[0050]
[0051]
[0052]
[0053]
[0054]
[0055]
[0056]
[0057]
[0058]
[0059]
[0060]
[0061]
DEFINITIONS
[0062] Various terms are used to refer to particular system components. Different companies may refer to a component by different namesthis document does not intend to distinguish between components that differ in name but not function. In the following discussion and in the claims, the terms including and comprising are used in an open-ended fashion, and thus should be interpreted to mean including, but not limited to . . . . Also, the term couple or couples is intended to mean either an indirect or direct connection. Thus, if a first device couples to a second device, that connection may be through a direct connection or through an indirect connection via other devices and connections.
[0063] Abutting [ ] heart tissue shall mean that a device is mechanically coupled to heart tissue such that the device moves with the heart during contract and relaxation of the heart tissue. The [ ] refers to the presence or absence of articles (e.g., a and the), and the presence or absence of articles shall not obviate applicability of the definition.
[0064] Electromagnetic waves shall mean alternating electric and magnetic fields propagating through a medium.
[0065] Substantially simultaneously in the context of a plurality microchip devices applying electrical energy shall mean the plurality of microchip devices starting the application of energy to the heart tissue within 200 microseconds of each other.
DETAILED DESCRIPTION
[0066] The following discussion is directed to various embodiments of the invention. Although one or more of these embodiments may be preferred, the embodiments disclosed should not be interpreted, or otherwise used, as limiting the scope of the disclosure, including the claims. In addition, one skilled in the art will understand that the following description has broad application, and the discussion of any embodiment is meant only to be exemplary of that embodiment, and not intended to intimate that the scope of the disclosure, including the claims, is limited to that embodiment.
[0067] Various embodiments are directed to systems and related methods to defibrillate or pace the heart when there is an arrhythmic event. This system may include a network of treatment devices (referred to herein as microchip devices) which may provide defibrillating and/or pacing. The microchip devices do not have batteries and are capable of applying electrical energy to the heart tissue. In some cases, microchip devices sense electrical impulses sourced by the heart, and send indications of the electrical impulses to a communication device that controls the array of microchip devices. The communication device may be wirelessly and communicatively coupled to the microchip devices to receive indications of electrical impulses in the heart, and to control application and timing of electrical energy for defibrillation and pacing. The description starts with a high level overview of the system, and then describes the various components in greater detail.
[0068]
[0069]
[0070] A bit more technically described then, in accordance with various embodiments microchip devices may be placed at any suitable location either epicardially or endocardially. The locations include placement in the coronary venous system (e.g., coronary sinus, middle cardiac vein, left posterior ventricular vein, left marginal vein, Vein of Marshall, anterior interventricular vein or the like), coronary arterial system, or combinations. In some embodiments, placement of the microchip devices 112 may include deploying in an arrangement within the vasculature, such that much of the left ventricle and a portion of the left atrium is covered, enabling epicardial pacing and defibrillation. The microchip devices may be deployed along the length of the coronary sinus and/or its branches and anchored in position for long-term use. The microchip devices 112 may be deployed along the length of the Vein of Marshall and anchored in position for long-term use. However, not all the noted placements need be used in every case.
[0071] Returning to
[0072] The example system further comprises communication device 114. Communication device 114 is communicatively coupled to the microchip devices 112. In particular, the communication device 114 in example embodiments is wirelessly coupled to the microchip devices 112, as illustrated by double-headed arrow 116. Various mechanisms for wireless communication between the communication device 114 and the microchip devices 112 are discussed more below. Suffice it to say at this stage that the communication device 114 may communicate individually to the microchip devices 112, and may also communicate to the microchip devices 112 as a group. The communication device 114 may take many forms. In some cases the communication device 114 resides outside the body containing the heart 100, and is physically placed abutting or proximate to the patient's skin. In other cases, the communication device 114 may be implanted under the patient's skin, such as subcutaneous placement between ribs of the patient. In yet still other cases, the functionality of the communication device 114 may be divided between a subcutaneously placed portion and an external portion, with the two portions communicatively coupled.
[0073] In example systems the communication device 114 controls the microchip devices 112. More particularly, the communication device 114 commands some or all the microchip devices 112 to apply electrical energy to the heart 100 to treat arrhythmias in the heart tissue. Consider, for example, the case of performing a defibrillation of the heart 100 (e.g., to treat an atrial fibrillation). In example defibrillation some or all the microchip devices 112 apply electrical energy to the heart tissue substantially simultaneously. Related-art defibrillation, both externally applied and internally applied, involves creating a large electrical field gradient across the heart (e.g., greater than 5V/cm). The energy needed for related-art defibrillation to be successful is generally above the pain threshold of 1 Joule (one Joule being the dissipation of one Watt for one second). Generation of such an electrical field and applying such energy in the related-art causes significant pain and trauma for the patient, damage to the myocardium, and in the case of defibrillation by implanted devices significantly reduced battery life. However, in accordance with example embodiments using a plurality of microchip devices 112 (e.g., ten or more, in some cases between 10 and 20), each microchip device 112 simultaneously applying a small and localized amount of energy together can provide sufficient overall energy to successfully perform defibrillation well below the pain threshold for the patient, thus reducing trauma for the patient and damage to the myocardium. For example, a defibrillation using the plurality of microchip devices 112 in proper placement (e.g., in and/or around the atrium) may be able to successfully defibrillate with between 0.07 and 0.8 Joules of energy.
[0074] Commanding the microchip devices 112 to apply energy substantially simultaneously can take many forms. In some cases, the communication device 114 may send a group message to all the microchip devices 112 simultaneously, the group message indicating that each device should apply energy immediately, or at a predetermined amount of time after the receiving the message (e.g., one millisecond). Considering that the distance between communication device 114 and each microchip device 112 will not be the same, the result may be slight differences in the start time of the application of energy, but given speed of propagation electromagnetic waves nevertheless would likely be within a few microseconds of each other. In other cases, each microchip device 112 is individually addressable by the communication device 114, and thus the commanding a defibrillation by the communication device 114 may involve communicating individually with each microchip device 112 and commanding application of energy. Even in the case of individually communicating with the microchip devices 112, the application of energy by each will still be within a few hundred microsecondswhich on the time scale of electrical impulses of the heart is simultaneous. Thus, substantially simultaneously in the context of microchip devices applying electrical energy shall mean the microchip devices starting the application of energy to the heart tissue within 200 microseconds.
[0075] Pacing, on the other hand, involves applying electrical energy to the heart in such a way as to mimic electrical impulse propagation through the heart tissue. Pacing can be beneficial for hearts that experience bradycardia (i.e., heart beating slower than normal) and tachycardia (i.e., heart beating faster than normal when at rest). Moreover, many hearts have scar tissue along the path of the electrical impulses, where the scar tissue may slow or block flow of electrical impulses through the heart, and pacing using a string or array of microchip devices may be beneficial for addressing issues associated with the electrical impulses and these scar tissue areas, such as re-entrant ventricular arrhythmias. The pacing across scar tissue is sometimes referred to as normalization of conduction velocity.
[0076] Thus, pacing involves a plurality of microchip devices 112 each applying electrical energy to the heart tissue, but for pacing the application is sequentially along a predefined path that includes or intersects the microchip devices 112. Still referring to
[0077] Commanding the microchip devices 112 to apply energy sequentially along the example pacing path 118 may rely on each microchip device 112 being individually addressable by the communication device 114 as discussed above. That is, commanding a pacing action by the communication device 114 may involve communicating individually and sequentially with each microchip device 112 along the pacing path and commanding application of energy. The speed of propagation of an electrical impulse along the heart muscles is very slow considered against, for example, the speed of propagation of electromagnetic waves even in the conductive environment of the body. Thus, the communication device 114 has sufficient time to individually address each microchip device 112 along the example pacing path 118 so as to apply a piecewise continuous pacing of electrical energy to the heart along any appropriate pacing path needed by the patient.
[0078] As mentioned above, some example microchip devices 112 may have the ability to sense electrical impulses sourced by and propagating within the heart. Example structures and systems to sense electrical impulses are discussed more below. Thus, in addition to or in place of applying electrical energy to the heart for purposes of defibrillation or pacing, a microchip device 112 may sense electrical impulses propagating through heart tissue. Sensing electrical impulses may trigger the microchip device 112 to wirelessly send a message to the communication device 114 responsive to the electrical impulses. In some embodiments the message sent wirelessly to the communication device 114 may be an indication that an electrical impulse was detected in a Boolean sense. In other cases, the message sent wirelessly to the communication device 114 may be an indication of the strength of the electrical impulses as measured (again, measuring techniques for electrical impulses discussed more below).
[0079] Regardless of the type of information sent in the message wirelessly between the microchip device 112 and the communication device 114 regarding the electrical impulses in the heart, the communication device 114 may utilize the information as part of a defibrillation and/or pacing action. For example, consider a microchip device located electrically upstream of scar tissue of the heart where the scar tissue blocks or significantly reduces the flow of electrical impulses in the heart tissue. In one example system, when the communication device 114 receives the indication from the microchip device about the electrical impulses, at an appropriate time thereafter the communication device 114 individually addresses and commands microchip devices electrically downstream of the scar tissue to apply pacing energy to the heart to trigger a continuance of the electrical impulse through the heart. The specification now turns to a description of example microchip devices 112.
[0080]
[0081] Both the capacitor 309 and the substrate 300 are mechanically coupled to an anchoring structure 310. The example anchoring structure 310 is made of any suitable biocompatible material that, for reasons discussed more below, has low conductivity yet sufficient structural strength and rigidity to support the substrate 300 and various other structures. The capacitor 309 and substrate are mechanically coupled to a first side 312 of the anchoring structure 310 opposite a bottom or second side 314 of the anchoring structure 310. While the various circuits 302, 304, 306, and 308 are shown on an upper or exposed side of the substrate 300, in some cases the substrate 300 may be mounted to the anchoring structure 310 in a flip-chip form with the circuits facing the first side 312 of the anchoring structure. An arrangement in flip chip form may protect the circuits during installation and use, and may also help facilitate electrical connections to various sets of electrodes and sets of conductive pads (discussed more below).
[0082] The energy harvesting circuit 302 is defined on the substrate and is electrically coupled to the capacitor 309. The energy harvesting circuit 302 is configured to extract electrical energy from energy propagating proximate the microchip device and to store electrical energy on the capacitor 309. Electrical energy stored on the capacitor 309 thus provides operational power to the remaining circuits of the example microchip device 112. The communication circuit 304 is defined on the substrate 300 and is electrically coupled to the energy harvesting circuit 302, from which the communication circuit 304 is provided power. The communication circuit 304 is configured to receive commands originating external to the microchip device 112, such as from the communication device 114 (
[0083]
[0084] The example microchip device 112 of
[0085]
[0086] Further visible in the view of
[0087] Further visible in the view of
[0088] Further visible in the view of
[0089] The example anchoring structure 310 is a non-conductive element, and thus the electrodes and conductive pads are electrically isolated from the standpoint of the anchoring structure. Electrical connections between the electrodes (or conductive pads) and their respective circuits (e.g., energy harvesting circuit 302, energy delivery circuit 306, and sensing circuit 308) may be made through holes or vias through the anchoring structure 310 to electrically couple to connection pads defined on the substrate 300 (not shown). In some cases, the anchoring structure may be a multi-level structure with electrical traces disposed on interposed layers to align the traces for electrical contact with the various circuits of the substrate 300.
[0090] The various microchip devices 112 discussed to this point are configured for placement to abut the heart tissue by way of a carrier structure to which a plurality of the microchip devices 112 is mechanically coupled. Stated otherwise, a carrier structure having a plurality of microchip devices may be used to place and hold each of the plurality of microchip devices 112 to abut the heart tissue at respective locations. The specification now turns to example carrier structures.
[0091]
[0092] The microchip devices 112 may be coupled to the stent 502 in any suitable form. For example, the microchip device 112 may be adhered to the metallic structure such that the bottom sides 314 of anchoring structures 310 (not visible in
[0093] Referring now to the lower drawing 506 of
[0094] Placing and expansion of the carrier structure 500 in the form a stent 502 may use now existing or after-developed technology for placement of stents. For example, the un-expanded stent 502 may be carried on or within the distal end of a catheter system and placed as needed within the coronary artery system. Once in place, a balloon catheter may be inflated to bend and expand the metallic material of the stent 502, and then the balloon deflated and the catheter removed leaving the stent 502 and the plurality of microchip devices 112 in place.
[0095]
[0096] Referring initially to the lower drawing 610 (though the elements introduced with respect to the lower drawing 610 are equally applicable to the middle and upper drawings). The catheter system 600, shown in partial cutaway view, comprises a catheter 612 that defines an internal lumen with an internal volume along the length L.sub.C of the catheter 612. The catheter 612 is of sufficient length for delivery into the coronary veins and/or arteries in a similar fashion to the delivery of stents discussed above. Disposed within the catheter 612 is a helical wire or spring 614 that has a diameter that abuts the inside diameter of the catheter 612 and extends along substantially the entire length L.sub.C of the catheter 612. The spring 614 terminates on the distal end 616 proximate a distal aperture of the lumen of the catheter 612. On the proximal end 618 the spring 614 mechanically couples to a knurled knob 620. Thus, turning of the knurled knob 620 results in rotation of the spring 614 within the catheter 612, the rotation about a longitudinal axis 622 of the spring 614 (which longitudinal axis 622 is coaxial with the longitudinal axis of the catheter 612). The carrier structure 602 in the example embodiments of
[0097] The lower drawing 610 of
[0098] Still referring to
[0099] Now referring to the upper drawings 606 of the
[0100] The microchip devices 112 may be coupled to the helical wire 604 in any suitable form. For example, the microchip devices 112 may be adhered to the helical wire such that the anchoring structures 310 (not visible in
[0101]
[0102] Using the catheter 700 the metallic wire 704 and microchip devices 112 may be placed into the coronary artery or vein system. As shown, placement may begin at a distal-most end of an artery or vein, and then proceed proximally. Though not specifically shown in
[0103] The various microchip devices 112 discussed in reference to
[0104]
[0105] The barbed pins 800 and 802 may be made of a nitinol structure; however, other materials may include stainless steel, titanium, and tungsten. The barbed pins may have coatings (such as hydrophilic or hydrophobic coatings to provide lubrication), or may be coated with antithrombogenic material.
[0106] In some embodiments, the barbed pins 800 and 802 provide only mechanical coupling of the microchip device 112 to the heart tissue. However, in other cases the barbed pins 800 and 802 not only provide for mechanical coupling, but also electrically couple the microchip device 112 to the heart tissue. That is, in some embodiments the set of electrodes by which the energy delivery circuit 306 (not shown in
[0107]
[0108]
[0109] Installation of the microchip device 112 of
[0110] In some embodiments, the helical screw 900 provides only mechanical coupling of the microchip device 112 to the heart tissue. However, in other cases the helical screw 900 not only provides for mechanical coupling, but also electrically couples the microchip device 112 to the heart tissue. That is, in some embodiments one electrode of the set of electrodes by which the energy delivery circuit 306 (not shown in
[0111]
[0112]
[0113] Considering first the energy harvesting circuit 302. In the various embodiments the microchip device 112 harvests ambient energy to provide operational power to the other devices and components on the substrate. In some cases, the microchip device 112 harvests ambient energy in the form of electromagnetic waves propagating near, around, and/or past the microchip device 112. To that end, some example energy harvesting circuits 302 implement an energy harvesting antenna 1000 illustratively shown as a dipole antenna. In example cases, the energy harvesting antenna 1000 has an operating frequency of 1 Mega-Hertz (MHz) or above, in some cases having an operating frequency of between 1 MHz and 10 GigaHertz (GHz) inclusive, and in specific cases between 100 MHz and 1 GHz inclusive. The energy harvesting antenna 1000 may be monolithically created on the substrate 300 by deposition of metallic material and selective etching to create metallic conductors. Other monolithically created antenna types may be equivalently used, such as bow tie antennas and patch antennas.
[0114] The energy harvesting antenna 1000 electrically couples to an impedance matching network 1002 (shown in block diagram form and labeled Z). As the name implies, the impedance matching network 1002 matches impedance between the energy harvesting antenna 1000 and the downstream devices to ensure low reflected energy and thus efficient energy transfer to the downstream devices. The impedance matching network 1002, in turn, electrically couples to the rectifier 1004. The rectifier 1004 rectifies the alternating current energy from the energy harvesting antenna 1000, and applies the energy to either an on-chip capacitor 1006, capacitor 309 associated with the substrate 300, or both. The block diagram form showing the rectifier 1004 illustratively shows a single diode; however, the rectifier may take any suitable form, including the half-wave rectification by way of a single diode, full-wave rectification by way of a diode bridge, and rectification by switches operated as diodes (to reduce energy loss in the form of diode voltage drop). In some cases, the rectifier 1004 directly applies the rectified energy to the capacitor 1006 and/or 309 (
[0115] The example energy harvesting circuit 302 further comprises a power management unit (PMU) 1008 defined on the substrate 300. The power management unit 1008 is electrically coupled to the capacitor 1006 and/or 309, and thus is electrically coupled to the unregulated voltage. In example systems, the power management unit 1008 comprises one or more circuits that selectively produce a regulated voltage (V.sub.REG) from the unregulated voltage. In some cases the regulated voltage may be about 1.0 Volts. The example power management unit 1008 also produces an enable signal 1010 coupled to various other of the circuits. In accordance with example embodiments, the power management unit 1008 de-asserts the enable signal 1010 during periods of time when the energy stored on the capacitor 1006 and/or 309 is below a predetermined threshold. With the remaining circuits disabled and thus not consuming power or consuming significantly reduced power, the energy harvesting circuit 302 can more quickly charge the capacitor 1006 and/or 309 from ambient energy. Once the energy stored reaches or exceeds the predetermined threshold (again, e.g., 1.6 V), the power management unit 1008 asserts the enable signal 1010 thus enabling the remaining circuits to operate, such as sensing electrical impulses by the sensing circuit 308, applying energy to the tissue by the energy delivery circuit 306, and sending and/or receiving communications by way of the communication circuit 304.
[0116] Still referring to
[0117] In operation, the communication device 114 (
[0118]
[0119] To send and receive messages, the radio 1016 is electrically coupled to communication antenna 1018, illustratively shown as a diploe antenna. In example cases, the communication antenna 1018 has an operating frequency above 1 MHz, in some cases having an operating frequency of between 1 MHz and 1 Giga-Hertz (GHz) inclusive, and in specific cases between 100 MHz and 1 GHz inclusive. The communication antenna 1018 may be monolithically created on the substrate 300 by deposition of metallic material and selective etching to create metallic conductors. Other monolithically created antenna types may be equivalently used, such as bow tie antennas and patch antennas.
[0120] Still referring the
[0121]
[0122] Sensing electrical impulses sourced by and propagating within the heart may take many forms. In one example system, the electrical impulses are sensed by way of their magnetic fields. That is, time varying electrical current flow induces magnetic fields. Inasmuch as the electrical impulses sourced by the heart are time varying, in one example system the electrical impulses are detected based on detection of associated magnetic fields. To that end, in some cases the substrate 300 may include a loop antenna 1028. The example loop antenna 1028 is shown to encircle all the other components, and is also shown to have only a single loop or turn. In other cases, the loop antenna 1028 may be disposed other than encircling the other components, and may contain multiple loops. The loop antenna 1028 may be monolithically created on the substrate 300 by deposition of metallic material and selective etching to create metallic conductors.
[0123] The example loop antenna 1028 is electrically coupled to rectifier 1024. The rectifier 1024 rectifies the electrical current induced on the loop antenna 1028, and then applies the rectified waveform to the AD converter 1026. The block diagram form showing the rectifier 1024 illustratively shows a single diode; however, the rectifier may take any suitable form, including the half-wave rectification by way of a single diode, full-wave rectification by way of a diode bridge, and rectification by switches operated as diodes. Thus, the electrical system comprising the loop antenna 1028, rectifier 1024, and AD converter 1026 may be used to detect presence of an electrical impulse, and to some extent the strength of the electrical impulse. In other cases, however, the rectifier 1024 may be omitted and the AD converter 1026 may thus digitize the waveform of the detected electrical impulse. The sensing circuit 308 may thus send an indication of the full waveform to the communication device 114 by way of the communication circuit 304, and thus the communication circuit may make defibrillation and/or pacing decisions based on the full waveform.
[0124] Still referring to
[0125]
[0126] The set of conductive pads 1034 may be electrically coupled to conductive electrodes 400 and 402 (
[0127] Biphasic coupling bridge 1030 couples between a source of electrical energy and the set of conductive pads 1034. In some cases, the source of electrical energy for defibrillation and/or pacing is derived from regulated voltage V.sub.REG (as shown by the bubble A (A prime) coupled to the biphasic coupling bridge 1032). In other cases, perhaps where higher voltage and/or current is needed, the source of electrical energy for defibrillation and/or pacing is derived from unregulated voltage V.sub.UNREG (as shown by the bubble A coupled to the biphasic coupling bridge 1032). The example biphasic coupling bridge 1032 comprises four electrically controlled switches 1036, 1038, 1040, and 1042. Although shown as contact switches so as not to unduly clutter the figure, in practice the switches may be any electrically controlled switch device, such as field effect transistors (FETs). The source of electrical energy (e.g., either the regulated voltage V.sub.REG or the unregulated voltage V.sub.UNREG) couples to an upper rail of the biphasic coupling bridge 1032, while the lower rail of the biphasic coupling bridge 1032 is connected to common or ground defined on the substrate 300. A first conductive pad of the set of conductive pads 1034 is coupled between electrically controlled switches in a first leg of the bridge (e.g., between electrically controlled switches 1036 and 1040), and a second conductive pad of the set of conductive pads 1034 is couple between electrically controlled switches in a second leg of the bridge (e.g., between electrically controlled switches 1038 and 1042).
[0128] Thus, by selective control of the electrically controlled switches 1036, 1038, 1040, and 1042, the energy delivery circuit 306 can apply electrical energy biphasically (i.e., with alternating polarities) if desired. Consider, as an example, that the energy delivery circuit 306 has received a command from the communication circuit to apply biphasic electrical energy for purposes of defibrillation and/or pacing. Initially, the biphasic coupling bridge may make electrically controlled switches 1036 and 1042 conductive, and make electrically controlled switches 1038 and 1040 non-conductive, thus applying the electrical energy across the conductive pads 1034 with a first polarity. After a predetermined amount of time, the processor 1014 may make electrically controlled switches 1036 and 1042 non-conductive, and make electrically controlled switches 1038 and 1040 conductive, thus applying the electrical energy across the conductive pads 1034 with a second polarity, opposite the first polarity. After a predetermined amount of time, the processor 1014 may make all the electrically controlled switches 1036 and 1042 non-conductive, thus ending the application of electrical energy to the heart tissue. In yet still other cases, the processor 1014 may command the biphasic coupling bridge to couple the electrical energy in only one, perhaps predetermined, polarity.
[0129] As a non-limiting example, the electrical current applied as part of the defibrillation and/or pacing can be positive or negative. The pulse width of the current may be varied from one microsecond to one second, and the amplitude of the electrical current may be varied from one micro-Amp to one Amp (e.g., by operating the electrically controlled switches 1036-1042 in the form of transistors within their active regions to control voltage drop across the transistors).
[0130]
[0131]
[0132]
[0133] The above discussion regarding energy harvesting related to electric fields applied to a sample volume is meant to be illustrative of the principles and various embodiments. Numerous variations and modifications will become apparent to those skilled in the art once the above disclosure is fully appreciated. It is intended that the following claims be interpreted to embrace all such variations and modifications.