DEVICES, SYSTEMS AND METHODS FOR USING AND MONITORING MEDICAL DEVICES

• US 20160310077A1
• Filed: 03/23/2016
• Published: 10/27/2016
• Est. Priority Date: 09/17/2014
• Status: Active Grant

• Current Assignee: Canary Medical, Inc.
• Original Assignee: Canary Medical, Inc.
• Inventors: Hunter, William L., Holberg, Douglas R., Gross, Jeffrey M.
• Granted Patent: US 10,492,686 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/74 Devices for the head or neck or trochanter of the femur trochanteric devices connected to the proximal part of an endoprosthetic femoral shaft A61F2/30739; endoprosthetic internal fixation devices for the head or neck of the femur A61F2/3601
• CPC Class Codes: A61B 17/80 Cortical plates , i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 2562/063 in a linear array
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• 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 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/02014 Determining aneurysm
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/02108 from analysis of pulse wave characteristics
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/4851 Prosthesis assessment or monitoring
• CPC Class Codes: A61B 5/6812 Orthopaedic devices
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 5/686 : Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/6862 : Stents
• CPC Class Codes: A61B 5/7275 : Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61C 8/00 : Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools fastening of peg-teeth in the mouth A61C13/30
• CPC Class Codes: A61F 2/0059 : Cosmetic or alloplastic implants A61F2/10 - A61F2/16, A61F2/28 take precedence
• CPC Class Codes: A61F 2/07 : Stent-grafts
• CPC Class Codes: A61F 2/16 : Intraocular lenses
• CPC Class Codes: A61F 2/2412 : with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/32 : for the hip
• CPC Class Codes: A61F 2/3859 : Femoral components
• CPC Class Codes: A61F 2/3877 : Patellae or trochleae
• CPC Class Codes: A61F 2/389 : Tibial components A61F2/3868 takes precedence
• CPC Class Codes: A61F 5/0123 : for the knees A61F5/0106 takes precedence
• CPC Class Codes: A61F 5/055 : Cervical collars
• CPC Class Codes: A61M 16/04 : Tracheal tubes catheters in general A61M25/00
• CPC Class Codes: A61M 2205/332 : Force measuring means
• CPC Class Codes: A61N 1/3702 : Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/3956 : Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: G16H 40/60 : for the operation of medical equipment or devices
• CPC Class Codes: G16H 40/63 : for local operation

Abstract

Medical devices are provided, comprising a medical device and a sensor.

Claims

1. A sensor module, comprising:

a sensor channel; and

a communication interface coupled to the sensor channel.

2. The sensor module of claim 1 wherein the sensor channel includes a sensor and a sensor channel coupled to the sensor and to the communication interface.

3. The sensor module of claim 1 wherein the sensor includes one or more of the following sensors:

a global-positioning-system (GPS), accelerometer, Hall-effect, electrical, magnetic, thermal, pressure, radiation, optical, quantity-differential, capacitive, inductive, and time.

4. The sensor module of claim 1 wherein the sensor is a microelectromechanical sensor (MEMS).

5. The sensor module of claim 1 wherein said sensor includes one or more of the following sensors:

fluid pressure sensors, fluid volume sensors, contact sensors, position sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, chemistry sensors, metabolic sensors, accelerometers, mechanical stress sensors and temperature sensors.

7. The sensor module of claim 1 wherein the communication interface is configured to communicate with another sensor module.

9. The sensor module of claim 1, further comprising a power supply coupled to the sensor and the communication interface and configured to harvest energy from an organism in which the sensor module is implanted.

11. The sensor module of claim 1, further comprising a controller coupled to the sensor channel and the communication interface.

13. A medical device, comprising:

a medical device; and

a sensor module according to claim 1.

14. The medical device according to claim 13, wherein said medical device is a cardiovascular device, orthopedic device, spinal device, intrauterine device, cochlear implant, aesthetic implant, dental implant, medical polymer or artificial eye lens.

21. The medical device according to claim 13, wherein said medical device is sterile.

22. The medical device according to claim 13, further comprising one or more passive sensors.

40. The medical device according to claim 13 wherein said sensor is a plurality of sensors which are positioned on or within said medical device at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per square centimeter.

41. The medical device according to claim 13 wherein said sensor is a plurality of sensors which are positioned on or within said medical device at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per cubic centimeter.

42. A method comprising:

obtaining data from sensors positioned at a plurality of locations between, on, and/or within the medical device according to claim 13 of a subject;

storing the data in a memory device located on or within the medical device; and

transferring the data from the memory to a location outside the medical device.

44. A method for detecting and/or recording an event in a subject with the medical device according to claim 13, comprising the step of interrogating at a desired point in time an activity of one or more sensors within the medical device, and recording said activity.

48. A method for imaging a medical device in a bone, comprising the steps of

(a) detecting a location of one or more sensors in the medical device according to claim 13;

and

(b) visually displaying the location of said one or more sensors, such that an image of the medical device, or a portion thereof, in the bone is created.

52. A method for inserting the medical device according to claim 13, comprising the steps of

(a) inserting the medical device into a subject to provide a placement of the medical device in the subject;

and

(b) imaging the placement of said medical device according to a method comprising;

obtaining data from sensors positioned at a plurality of locations between, on, and/or within the medical device located in the subject; and

visually displaying a relative anatomical location of said sensors such that an image of the medical device is created.

53. A method for examining the medical device according to claim 13 which has been previously inserted into a patient, comprising the step of imaging the medical device according to a method comprising:

obtaining data from sensors positioned at a plurality of locations between, on, and/or within the medical device located in the patient; and

visually displaying a relative anatomical location of said sensors such that an image of the medical device is created.

54. A method of monitoring a medical device within a subject, comprising:

(a) transmitting a wireless electrical signal from a location outside the body to a location inside the subject'"'"'s body;

(b) receiving the signal at a sensor positioned on a medical device according claim 13 located inside the body;

(c) powering the sensor using the received signal;

(d) sensing data at the sensor; and

(e) outputting the sensed data from the sensor to a receiving unit located outside of the body.

59. A non-transitory computer-readable storage medium whose stored contents configure a computing system to perform a method, the method comprising:

(a) identifying a subject, the identified subject having at least one wireless medical device according to claim 13, each wireless medical device having one or more wireless sensors;

(b) directing a wireless interrogation unit to collect sensor data from at least one of the respective one or more wireless sensors; and

(c) receiving the collected sensor data.

60. The non-transitory computer-readable storage medium of claim 59 whose stored contents configure a computing system to perform a method, the method further comprising:

(a) identifying a plurality of subjects, each identified subject having at least one medical device, each medical device having one or more wireless sensors;

(b) directing a wireless interrogation unit associated with each identified subject to collect sensor data from at least one of the respective one or more wireless sensors;

(c) receiving the collected sensor data; and

(d) aggregating the collected sensor data.

61. The non-transitory computer-readable storage medium of claim 60 whose stored contents configure a computing system to perform a method, the method further comprising:

(a) removing sensitive subject data from the collected sensor data; and

(b) parsing the aggregated data according to a type of sensor.

63. The non-transitory computer readable storage medium according to claim 60, wherein said medical device comprises a medical device and a sensor module, and said sensor module comprises a sensor channel and a communication interface coupled to the sensor channel.

71. A method for determining degradation of a medical device, comprising the steps of:

a) providing to a subject a medical device according to claim 13, and

b) detecting a change in a sensor, and thus determining degradation of the medical device.

76. A method for determining an infection associated with a medical device, comprising the steps of

a) providing to a subject a medical device according to claim 13, wherein said medical device comprises at least one temperature sensor and/or metabolic sensor, and

b) detecting a change in said temperature sensor and/or metabolic sensor, and thus determining the presence of an infection.

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24. A method, comprising:

sensing a physical quantity; and

generating a representation of the sensed quantity.

30. The method of claim 24, further comprising:

wherein the sensing and generating are performed by a first sensor module; and

transmitting wirelessly the representation of the sensed quantity to a second sensor module that is remote from the first sensor module.

31. The method of claim 24, further comprising:

wherein the sensing and generating are performed by a first sensor module; and

receiving with the first sensor module data from a second sensor module that is remote from the first sensor module.

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33. A system, comprising:

a sensor module including a battery; and

a battery charger configured to charge the battery wirelessly.

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35. A system, comprising:

a first sensor module; and

a second sensor module configured to communicate with the first sensor module.

37. The system of claim 35 wherein at least one of the first and second sensor modules is configured to be attached to an organism.

39. The system of claim 35 wherein one of the first and second sensor modules is configured to power the other of the first and second sensor modules.

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