Medical device

• US 9,526,920 B2
• Filed: 10/12/2011
• Issued: 12/27/2016
• Est. Priority Date: 10/12/2010
• Status: Active Grant

• Current Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Original Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Inventors: Umstead, Kelly Ann, Tanis, Kevin J., Zhang, Jin, Arrington, Debra Ann
• Primary Examiner(s): Cattungal, Sanjay
• Application Number:
  US13/271,870
• Publication Number:
  US 20120165620A1
• Time in Patent Office: 1,903 Days
• Field of Search: 601 2- 3, 705/4, 705/64, 600437-469, 607/59, 700213-237, 235381-385
• US Class Current: 1/1
• CPC Class Codes: A61B 2034/258 providing specific settings for specific users
• CPC Class Codes: A61B 2090/0803 Counting the number of times an instrument is used
• CPC Class Codes: A61B 34/25 User interfaces for surgical systems
• CPC Class Codes: A61B 5/1172 using fingerprinting
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags
• CPC Class Codes: A61M 2205/6009 for matching patient with his treatment, e.g. to improve transfusion security
• CPC Class Codes: A61N 2007/0013 Fracture healing
• CPC Class Codes: A61N 2007/0078 with multiple treatment transducers
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: H04L 67/12 specially adapted for proprietary or special-purpose networking environments, e.g. medical networks, sensor networks, networks in vehicles or remote metering networks

Abstract

A medical device includes a treatment module configured to apply a treatment to a patient. The medical device includes an interface configured to operatively connect to a removable storage device storing authorization data that identifies a level of treatment authorization. The medical device includes a processing device configured to perform operations in response to receiving user input indicating a treatment should be initiated. The operations include determining whether the removable storage device is valid for use with the medical device. If the removable storage device is determined to be valid, the authorization data is accessed. The processing device determines whether the treatment is authorized based on the accessed authorization data. If the treatment is determined to be authorized, the treatment module is controlled to apply the treatment. If the treatment is determined to not be authorized, the treatment module is controlled such that the treatment is not applied.

Claims

1. A medical device comprising:

at least one treatment source configured to couple to damaged tissue and apply therapy to the damaged tissue to stimulate healing;

a memory device configured to store authorization data, the authorization data being usable to determine that a patient is authorized to use the at least one treatment source in a first geographic area and unauthorized to use the at least one treatment source in a second geographic area;

a communication module configured to receive an update to the authorization data via a communication network, the update being usable to determine that the patient is authorized to use the at least one treatment source in the second geographic area; and

at least one processing device configured to;

prior to receiving the update with the communication module,

determine from the authorization data that the patient is authorized to use the at least one treatment source in the first geographic area and unauthorized to use the at least one treatment source in the second geographic area,

receive a first user input indicating to initiate therapy with the at least one treatment source,

determine a first location of the at least one treatment source in response to receiving the first user input,

permit application of therapy by the at least one treatment source in response to determining that the patient is authorized to use the at least one treatment source and that the first location is in the first geographic area,

receive a second user input indicating to initiate therapy with the at least one treatment source,

determine a second location of the at least one treatment source in response to receiving the second user input, and

prevent application of therapy by the at least one treatment source in response to determining that the second location is in the second geographic area, receive the update with the communication module, and

subsequent to receiving the update with the communication module,

determine from the authorization data and the update that the patient is authorized to use the at least one treatment source in the second geographic area,

receive a third user input indicating to initiate therapy with the at least one treatment source,

determine a third location of the at least one treatment source in response to receiving the third user input, and

permit application of therapy by the at least one treatment source in response to determining that the patient is authorized to use the at least one treatment source and that the third location is in the second geographic area.

2. The medical device of claim 1, wherein the communication network is a wireless communication network.

3. The medical device of claim 2, wherein the wireless communication network is a cellular wireless communication network.

4. The medical device of claim 1, wherein:

the memory device stores a device identifier;

the authorization data is encrypted; and

the at least one processing device is further configured to decrypt the authorization data using the device identifier.

5. The medical device of claim 1, further comprising a sensor configured to receive a first authentication input from the patient, wherein:

the at least one processing device is configured to;

prior to receiving the update with the communication module,

determine from the first authentication input that the patient is using the at least one treatment source, and

permit application of therapy by the at least one treatment source in response to determining that (i) the patient is authorized to use the at least one treatment source, (ii) that the first location is in the first geographic area, and (iii) the patient is using the at least one treatment source, and

subsequent to receiving the update with the communication module,

determine from the first authentication input that the patient is using the at least one treatment source, and

permit application of therapy by the at least one treatment source in response to determining that (i) the patient is authorized to use the at least one treatment source, (ii) that the third location is in the second geographic area, and (iii) the patient is using the at least one treatment source.

6. The medical device of claim 5, wherein the first authentication input comprises a fingerprint image.

7. The medical device of claim 5, wherein the first authentication input comprises a retinal image.

8. The medical device of claim 5, wherein the first authentication input comprises a voice recording.

9. The medical device of claim 5, wherein:

the sensor is configured to receive a second authentication input from an individual other than the patient; and

the at least one processing device is configured to;

prior to receiving the update with the communication module,

determine from the second authentication input that the patient is attended to by the individual while using the at least one treatment source, and

permit application of therapy by the at least one treatment source in response to determining that (i) the patient is authorized to use the at least one treatment source, (ii) that the first location is in the first geographic area, (iii) the patient is using the at least one treatment source, and (iv) the patient is attended to by the individual while using the at least one treatment source, and

subsequent to receiving the update with the communication module,

determine from the second authentication input that the patient is attended to by the individual while using the at least one treatment source, and

permit application of therapy by the at least one treatment source in response to determining that (i) the patient is authorized to use the at least one treatment source, (ii) that the third location is in the second geographic area, (iii) the patient is using the at least one treatment source, and (iv) the patient is attended to by the individual while using the at least one treatment source.

10. The medical device of claim 1, further comprising an alarm indicator, wherein:

the at least one processing device is configured to;

prior to receiving the update with the communication module,

activate the alarm indicator in response to determining that the second location is in the second geographic area.

11. The medical device of claim 1, wherein:

the at least one treatment source comprises a driver circuit configured to control application of therapy to the damaged issue; and

the at least one processing device is configured to permit application of therapy by activating the driver circuit.

12. The medical device of claim 1, wherein:

the at least one treatment source comprises a driver circuit configured to control application of therapy to the damaged issue; and

the at least one processing device is configured to permit application of therapy by not deactivating the driver circuit.

13. The medical device of claim 1, wherein:

the at least one treatment source comprises a driver circuit configured to control application of therapy to the damaged issue; and

the at least one processing device is configured to prevent application of therapy by not activating the driver circuit.

14. The medical device of claim 1, wherein:

the at least one treatment source comprises a driver circuit configured to control application of therapy to the damaged issue; and

the at least one processing device is configured to prevent application of therapy by deactivating the driver circuit.

15. The medical device of claim 1, wherein:

the at least one treatment source comprises a driver circuit configured to control application of therapy to the damaged issue; and

the at least one processing device is configured to prevent application of therapy by setting an output of the driver circuit.

16. The medical device of claim 1, wherein the communication module is configured to receive the update via the communication network from a server system.

17. The medical device of claim 1, further comprising a GPS receiver configured to determine a geographical location of the at least one treatment source, and the at least one processing device is configured to determine the first location from the GPS receiver.

18. The medical device of claim 1, further comprising a user interface configured to receive the first user input, the second user input, and the third user input as selections of at least one element of the user interface.

19. A computer-implemented method comprising:

determining from authorization data that a patient is authorized to use at least one treatment source of a medical device in a first geographic area, the authorization data being accessed from a memory device of the medical device and usable to determine that the patient is authorized to use the at least one treatment source in the first geographic area and unauthorized to use the at least one treatment source in a second geographic area, the at least one treatment source being configured to couple to damaged tissue of the patient;

receiving a first user input indicating to initiate therapy with the at least one treatment source;

determining a first location of the at least one treatment source in response to receiving the first user input;

performing therapy to the damaged issue to stimulate healing in response to determining that the patient is authorized to use the at least one treatment source and that the first location is in the first geographic area;

receiving an update to the authorization data via a communication network, the update being usable to determine that the patient is authorized to use the at least one treatment source in the second geographic area;

determining from the authorization data and the update that the patient is authorized to use the at least one treatment source in the second geographic area;

receiving a second user input indicating to initiate therapy with the at least one treatment source;

determining a second location of the at least one treatment source in response to receiving the second user input; and

performing therapy to the damaged issue to stimulate healing in response to determining that the patient is authorized to use the at least one treatment source and that the second location is in the second geographic area.

20. The computer-implemented method of claim 19, wherein the communication network is a wireless communication network.

21. The computer-implemented method of claim 20, wherein the wireless communication network is a cellular wireless communication network.