Implantable wireless sensor systems

• US 10,022,054 B2
• Filed: 06/08/2012
• Issued: 07/17/2018
• Est. Priority Date: 06/08/2011
• Status: Active Grant

• Current Assignee: UIM Pressure Implant Incorporated
• Original Assignee: Integrated Sensing Systems Incorporated
• Inventors: Najafi, Nader, Baranowski, Jacek Rysard, Goetzinger, David Joseph
• Primary Examiner(s): Downey, John R
• Assistant Examiner(s): JIAN, SHIRLEY XUEYING
• Application Number:
  US13/492,185
• Publication Number:
  US 20130144379A1
• Time in Patent Office: 2,230 Days
• Field of Search: 606232
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• CPC Class Codes: A61B 5/0024 for multiple sensor units attached to the patient, e.g. using a body or personal area network
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/02158 provided with two or more sensor elements
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/302 for capacitive or ionised electrodes, e.g. metal-oxide-semiconductor field-effect transistors [MOSFET]
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2478 Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
• CPC Class Codes: F04C 2270/041 Controlled or regulated

Abstract

In some embodiments, a cardiac monitoring system includes multiple sensors configured for implantation in a cardiovascular system of a user. Each sensor includes a sensing unit configured to be disposed in sensory communication with the location for measuring a biological parameter in the at least one heart chamber. The sensing unit is also configured to generate a sensory signal associated with the biological parameter. Each sensor also includes a wireless transceiver configured to receive the sensory signal from the sensing unit. The wireless transceiver is further configured to wirelessly transmit the sensory signal to an external processing device disposed outside a body of the user. The external processing device monitors, based on the sensory signal received from at least two sensors from the plurality of sensors, cardiac health associated with at least one of an implanted device or a surgery.

Claims

1. A cardiac monitoring system, comprising:

a plurality of sensors configured for implantation in a cardiovascular system of a user, each sensor from the plurality of sensors including;

a sensing unit configured to be disposed in sensory communication with a location in the cardiovascular system for measuring a biological parameter in the location, said sensing unit configured to generate a sensory signal associated with the biological parameter;

a button portion defining a distal side, a proximal side opposite the distal side, and a plurality of apertures configured to receive a suture for anchoring the sensing unit in sensory communication with the location, the plurality of apertures collectively having a cross-sectional area less than a cross-sectional area of the proximal side of the button portion;

an elongate portion extending from the distal side of the button portion and having a diameter smaller than a diameter of the button portion, the button portion being configured to occlude an aperture defined by the cardiovascular system and having a width sufficient to receive the elongate portion, the elongate portion defining a cavity in which the sensing unit is disposed; and

a wireless transceiver configured to receive the sensory signal from the sensing unit and configured to wirelessly transmit the sensory signal to an external processing device disposed outside a body of the user such that the external processing device monitors, based on the sensory signal received from the plurality of sensors, cardiac health associated with at least one of an implanted device or a surgery.

2. The system of claim 1, wherein the sensing unit is configured to be disposed in sensory communication with at least one of a heart chamber, a heart wall, a vein, or an artery.

3. The system of claim 1, wherein:

at least one sensor from the plurality of sensors does not communicate a sensory signal to a remaining sensor from the plurality of sensors; and

at least one sensor from the plurality of sensors does not directly communicate a sensory signal to the implanted device.

4. The system of claim 1, wherein:

at least one sensor from the plurality of sensors directly communicates a sensory signal to the implanted device; and

the external processing unit directly communicates with the implanted device.

5. The system of claim 1, wherein at least one sensor from the plurality of sensors is a cylindrical sensor, the cylindrical sensor includes a hollow cylindrical anchor including the button portion and is configured to anchor the cylindrical sensor to the location.

6. The system of claim 5, wherein a length of the cylindrical anchor is selected as a function of a wall thickness of the aperture defined by the cardiovascular system.

7. The system of claim 1, wherein at least one sensor from the plurality of sensors is a multipart assembly sensor.

8. The system of claim 7, wherein:

the multipart assembly sensor has a multipart sensing assembly including at least a sensing subassembly and a non-sensing subassembly;

the sensing subassembly includes the sensing unit and the non-sensing subassembly includes the wireless transceiver;

the sensing subassembly is configured to be implanted within a heart of the user;

the non-sensing subassembly is configured to be placed outside the heart of the user; and

the sensing subassembly is configured to be at least one of mechanically coupled or electrically coupled to the non-sensing subassembly.

9. The system of claim 1, wherein each sensor from the plurality of sensors includes an anchoring mechanism for anchoring each sensor from the plurality of sensors to the location, said anchoring mechanism for each sensor from the plurality of sensors including at least one of a compression fit anchor, at least one bolt, at least one screw, a mesh portion, at least one stent, at least one spring, at least one stitch, or at least one expanding tine.

10. The system of claim 1, wherein the biological parameter monitored by each sensor from the plurality of sensors includes at least one of a blood pressure, a temperature, a blood pH, conductivity, a dielectric constant, a chemical concentration, a gas content, or a metabolite.

11. The system of claim 1, wherein the sensing unit of at least one sensor from the plurality of sensors is a capacitive sensing unit including at least one flexible electrode attached to a substrate and at least one rigid electrode formed on the substrate.

12. The system of claim 1, wherein the wireless transceiver of at least one sensor from the plurality of sensors is configured to receive, from an external powering device disposed outside the body of the user, a power signal for powering the at least one sensor.

13. The system of claim 12, wherein the wireless transceiver includes at least one induction coil configured to (1) transmit the sensory signal and (2) receive the power signal.

14. The system of claim 1, wherein:

the external processing device is configured to at least one of wirelessly monitor the plurality of sensors, wirelessly control the plurality of sensors, or wirelessly charge the plurality of sensors, and

the external processing device is configured to at least one of wirelessly monitor the implanted device or wirelessly control the implanted device.

15. The system of claim 1, wherein the implanted device is at least one of a ventricular assist device (VAD) or a replacement valve.

16. The method of claim 1, wherein the surgery includes at least one of a coronary artery bypass graft (CABG), a valve repair, a transcatheter aortic valve operation, a catheter-based operation, open chest surgery, interventional operation, catheter-based surgery, percutaneous operation, hybrid operation, or a minimally invasive surgery.

17. The system of claim 1, wherein the button portion defines a device connector extending from the button portion, the device connector configured to couple to a device otherwise physically separate from the button portion.

18. The system of claim 1, further comprising:

the suture, the suture having an anchor portion and an elongate portion, a portion of the elongate portion of the suture configured to be routed through the plurality of apertures, and the anchor portion defined such that the anchor portion is prevented from being routed through the plurality of apertures of the button portion.

19. The system of claim 18, wherein:

the anchor portion of the suture having a curved shape.

20. The system of claim 1, wherein each aperture from the plurality of apertures is configured to receive a different suture for anchoring the sensing unit in sensory communication with the location, the plurality of apertures spaced circumferentially about the button portion.

21. The system of claim 1, wherein the plurality of apertures are spaced circumferentially about the button portion, each aperture from the plurality of apertures being equidistant from a central longitudinal axis of the elongate portion.

22. The system of claim 1, wherein the plurality of apertures are spaced circumferentially and uniformly about the button portion.

23. The system of claim 1, wherein a device connector extends along a longitudinal axis substantially parallel to a longitudinal axis of the elongate portion, the device connector having a length less than a length of the elongate portion.

24. The system of claim 1, wherein a device connector extends from the distal side of the button portion.

25. The system of claim 1, wherein the wireless transceiver is disposed within the cavity defined by the elongate portion.

26. The system of claim 1, wherein the cavity is in fluidic communication with the location in the cardiovascular system when the sensing unit is disposed in sensory communication with the location.

27. A method, comprising:

measuring a first biological parameter using a first sensor implanted in a wall of a first chamber of a heart of a user, the first sensor including (1) a button portion defining at least one aperture configured to receive a suture for anchoring the first sensor in sensory communication with the first chamber of the heart, (2) a device connector extending distally from a distal side of the button portion and configured to couple to a device otherwise physically separate from the first sensor, and (3) an elongate portion extending from the button portion;

generating a first sensory signal associated with the first biological parameter;

wirelessly transmitting, by the first sensor, the first sensory signal to an external processing device located outside the body of the user;

measuring a second biological parameter at a second sensor implanted in a wall of a second chamber of the heart;

generating a second sensory signal associated with the second biological parameter; and

wirelessly transmitting, by the second sensor, the second sensory signal to the external processing device; and

monitoring, based on at least one of the first sensory signal or the second sensory signal, cardiac health associated with at least one of an implanted device or a surgery.

28. The method of claim 27, wherein the implanted device does not directly receive the first sensory signal from the first sensor, the implanted device does not directly receive the second sensory signal from the second sensor.

29. The method of claim 27, wherein at least one of the first sensor or the second sensor is one of a cylindrical sensor, a flat sensor, or a multipart assembly sensor including a sensing subassembly and a non-sensing subassembly, the first sensor being selected as a function of the wall of the first chamber of the heart.

30. The method of claim 27, wherein the first biological parameter and the second biological parameter each include at least one of a blood pressure, a temperature, a blood pH, a conductivity, a dielectric constant, a chemical concentration, a gas content, or a metabolite.

31. The method of claim 27, further comprising receiving, at the first ensor a power signal from the external processing device for powering the first sensor.

32. The method of claim 27, wherein the monitoring includes monitoring, at the external processing device, at least one of:

a datum associated with the first sensory signal;

a datum associated with the second sensory signal;

a datum associated with the implanted device;

or

a datum associated with the monitored cardiac health.

33. The method of claim 27, further comprising at least one of:

wirelessly monitoring at least one of the first sensor or the second sensor;

wirelessly controlling at least one of the first sensor or the second sensor;

or

wirelessly charging at least one of the first sensor or the second sensor, and at least one of;

wirelessly monitoring the implanted device;

wirelessly controlling the implanted device;

or

wirelessly charging the implanted device.

34. The method of claim 27, further comprising implanting the first sensor via the suture placed in one or more placement catheters during at least one of implantation of the implanted device or the surgery.

35. The method of claim 34, further comprising pre loading the first sensor onto the suture prior to the at least one of implantation of the implanted device or the surgery.

36. The method of claim 35, wherein the suture includes a rail suture and a purse suture, said pre-loading including loading the first sensor onto the rail suture.

37. The method of claim 27, wherein a surgical site is formed due to at least one of implantation of the implanted device or the surgery, the method further comprising at least one of:

implanting at least one of the first sensor or the second sensor in the surgical site;

or

passing at least one of the first sensor or the second sensor through the surgical site for implantation in a site different from the surgical site.

38. The method of claim 27, wherein the implanted device is at least one of a ventricular assist device (VAD) or a replacement valve.

39. A method, comprising:

implanting in a patient a medical device;

implanting in a first location of a cardiovascular system of the patient a first sensing device in sensory communication with the first location, the first sensing device operable to measure a first biological parameter in the first location relevant to a performance of the medical device and to wirelessly transmit via a wireless transmitter a first signal representative of the first biological parameter to an external processing, device disposed outside a body of the patient, the first sensing device including a button portion and an elongate portion extending from the button portion and having a diameter smaller than a diameter of the button portion, the elongate portion defining a cavity in which the wireless transmitter is disposed, the button portion being configured to occlude an aperture defined by the cardiovascular system and having a width sufficient to receive the elongate portion, the button portion defining a plurality of apertures each configured to receive a suture for anchoring the first sensing device in sensory communication with the first location, the plurality of apertures collectively having a cross-sectional area less than a cross-sectional area of a proximal side of the button portion;

implanting in a second location of the cardiovascular system of the patient a second sensing device in sensory communication with the second location, the second sensing device operable to measure a second biological parameter in the second location relevant to the performance of the medical device and to wirelessly transmit a second signal representative of the second biological parameter to the external processing device; and

placing into operative wireless communication with each of the first sensing device and the second sensing device the external processing device, the external processing device operable to monitor operation of the medical device based on the first signal and the second signal.

40. The method of claim 39, wherein at least one of the first sensing device or the second sensing device is a pressure sensor, the implanting the first sensing device includes implanting the first sensing device during implantation of the medical device.

41. The method of claim 39, wherein the first location and the second location each include at least one of a wall of the left atrium, a wall of the right atrium, a wall of a left ventricle, a wall of a right ventricle, an interatrial septum, an interventricular septum, an atrioventricular septum, a wall of a vein, or a wall of an artery.

42. The method of claim 39, wherein the implanting the first sensing device in the first location includes implanting the first sensing device in a surgical site formed due to implantation of the medical device.

43. The method of claim 39, wherein the medical device is at least one of a ventricular assist device (VAD) or a replacement valve.

44. A cardiac monitoring system, comprising:

a plurality of sensors configured for implantation in a cardiovascular system of a user, each sensor from the plurality of sensors including;

a sensing unit configured to be disposed in sensory communication with a location in the cardiovascular system for measuring a biological parameter in the location, said sensing unit configured to generate a sensory signal associated with the biological parameter;

a button portion defining at least one aperture configured to receive a suture for anchoring the sensing unit in sensory communication with the location;

a device connector extending from the button portion and configured to couple to a device otherwise physically separate from that sensor;

an elongate portion extending from the button portion and having a diameter smaller than a diameter of the button portion, the button portion being configured to occlude an aperture defined by the cardiovascular system and having a width sufficient to receive the elongate portion;

the elongate portion and the device connector both extending distally from a same surface of the button portion; and

a wireless transceiver configured to receive the sensory signal from the sensing unit and configured to wirelessly transmit the sensory signal to an external processing device disposed outside a body of the user,

such that the external processing device monitors, based on the sensory signal received from the plurality of sensors, cardiac health associated with at least one of an implanted device or a surgery.

45. The system of claim 44, wherein the elongate portion extends from the button portion in a direction substantially parallel to a direction in which the device connector extends from the button portion.

46. The system of claim 44, wherein at least one of the sensing unit or the wireless transceiver is disposed in a cavity defined by the elongate portion.