Alignment of external medical device relative to implanted medical device

• US 6,138,681 A
• Filed: 10/13/1997
• Issued: 10/31/2000
• Est. Priority Date: 10/13/1997
• Status: Expired due to Fees

• Current Assignee: Light Sciences Corporation
• Original Assignee: Light Sciences Limited Partnership
• Inventors: Chen, James C., Wilkerson, Brian D., Huston, Darrin
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US08/949,308
• Time in Patent Office: 1,114 Days
• Field of Search: 128/897.99, 128/653.1, 607/156
• US Class Current: 128/899
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants

Abstract

The alignment and positioning of an external device relative to an internal device is indicated on a display and/or by an acoustical signal. In the disclosed application, the external device transcutaneously transmits electromagnetic energy to an internal receiver to provide electrical power for an implanted medical device. To ensure optimal coupling between the external transmitter and the internal receiver, two permanent magnets are disposed at spaced-apart positions on the internal receiver. The magnetic field strength of the permanent magnets is sensed by a pair of correspondingly spaced-apart Hall effect sensor on the external transmitter. As the external transmitter is moved about over the internal receiver, the signals produced by the Hall effect sensors drive a display of light emitting diodes (LEDs) that indicates when the maximum magnetic field strength is achieved, i.e., when the Hall effect sensors on the external transmitter are each positioned directly opposite the corresponding permanent magnets on the internal receiver.

Claims

1. Apparatus for determining a position of an external device relative to an implanted device that is separated from the external device by tissue, to enable said external device to be aligned with the implanted device, comprising:

(a) a magnet disposed on the external device;

(b) a magnetic field sensor disposed on the implanted device, said magnetic field sensor producing a signal indicative of a magnetic field strength; and

(c) an indicator coupled to the magnetic field sensor to receive the signal, said indicator providing an indication of the position of the external device relative to the implanted device as a function of the magnetic field strength sensed by the magnetic field sensor as said external device is moved adjacent to the implanted device, such that the indicator alerts a user when said external device is aligned with said implanted device.

2. Apparatus for determining a position of an external device relative to an implanted device that is separated from the external device by tissue, to enable said external device to be aligned with the implanted device, comprising:

(a) a magnet disposed on one of the external device and the implanted device;

(b) a magnetic field sensor disposed on another of the external device and the implanted device, said magnetic field sensor producing a signal indicative of a magnetic field strength;

(c) an indicator coupled to the magnetic field sensor to receive the signal, said indicator providing an indication of the position of the external device relative to the implanted device as a function of the magnetic field strength sensed by the magnetic field sensor as said external device is moved adjacent to the implanted device, such that the indicator alerts a user when said external device is aligned with said implanted device;

(d) another magnet disposed on one of the external device and the implanted device;

(e) another magnetic field sensor disposed on another of the external device and the implanted device, said other magnetic field sensor producing another signal indicative of a magnetic field strength; and

(f) another indicator coupled to the other magnetic field sensor to receive the other signal, said other indicator providing an indication of the position and orientation of the external device relative to the implanted device as a function of the magnetic field strength sensed by the other magnetic field sensor as said external device is moved adjacent to the implanted device.

3. The apparatus of claim 2, wherein the magnetic field sensor comprises one of a Hall effect sensor and a magneto resistive sensor.

4. The apparatus of claim 2, wherein the magnetic field sensors are disposed at spaced-apart locations on the external device.

5. The apparatus of claim 2, wherein the magnets are disposed at spaced-apart locations on the implanted device.

6. The apparatus of claim 2, wherein the indicator comprises a plurality of light sources and a driver circuit coupled to receive the signal, said driver circuit selectively energizing specific ones of the light sources as an indication of the field strength, and thus, of the position of the external device relative to the implanted device.

7. Apparatus for determining a position and alignment of an external device relative to an implanted device, to enable the external device to be aligned with the implanted device, said implanted device being separated from the external device by tissue, comprising:

(a) two magnets disposed in the implanted device at spaced-apart locations;

(b) two magnetic field sensors disposed in the external device at spaced-apart locations generally corresponding to the spaced-apart locations of the magnets in the implanted device, said magnetic sensors each producing an electrical signal indicative of magnetic field strength; and

(c) an indicator coupled to receive the signals produced by the magnetic field sensors and in response thereto, producing an indication of the magnetic field produced by the magnets and thus of a position and orientation of the external device relative to the implanted device, said indication enabling the external device to be moved to a position opposite to and aligned with the implanted device.

8. The apparatus of claim 7, wherein the indicator comprises a plurality of light sources arranged in an array, at least one of said plurality of light sources being energized to indicate a relative alignment of one of the magnets with one of the magnetic field sensors, at least another of said plurality of light sources being energized to indicate a relative alignment of the other of the magnets with the other of the magnetic field sensors.

9. The apparatus of claim 7, wherein the plurality of light sources are arranged side by side, forming a first section and a second section, said at least one of the light sources that is energized being in said first section, and said at least another of said light sources that is energized being in said second section, a disposition of each of the light sources that are energized in said first and second sections indicating the relative magnetic field strengths.

10. The apparatus of claim 7, wherein the magnetic field sensors each comprises one of a Hall effect sensor and a magneto resistive sensor.

11. The apparatus of claim 7, wherein the magnets are oriented so that their poles are in opposite directions.

12. The apparatus of claim 7, wherein the magnets are oriented so that their poles are in the same directions.

13. The apparatus of claim 7, further comprising:

(a) another magnet disposed in the implanted device at another location that is substantially spaced apart from a line through said two magnets;

(b) another magnetic field sensor disposed on the external device at another location that is substantially spaced apart from a line through said two magnetic field sensors and generally corresponds to the location of the other magnet on the implanted device, the other magnetic sensor producing an electrical signal indicative of magnetic field strength; and

(c) an indicator coupled to receive the signals produced by the other magnetic field sensor and in response thereto, producing an indication of the magnetic field produced by the other magnet and thus of a position and tilt of the external device relative to the implanted device, said indication enabling the external device to be moved to a position opposite to and aligned with the implanted device.

14. The apparatus of claim 7, wherein the indicator comprises an audible signal having at least two distinguishable characteristics, one characteristic varying with misalignment of one of the magnets relative to one of the magnetic field sensors, and another characteristic varying with misalignment of the other of the magnets relative to the other of the magnetic field sensors.

15. A method for determining a position of an external device in relation to an implanted device that is disposed within a patient'"'"'s body and separated from the external device by tissue to enable the external device to be located in a desired position relative to the implanted device, comprising the steps of:

(a) producing a magnetic field at a defined position on the external device;

(b) sensing the magnetic field at a defined position on the implanted device, and in response thereto, producing a signal indicative of a strength of the magnetic field at the defined position on said external device; and

(c) displaying an indication of the strength of the magnetic field sensed as the external device is moved relative to the implanted device, said indication enabling the external device to be located in the desired position relative to the implanted device.

16. A method for determining a position of an external device in relation to an implanted device that is disposed within a patient'"'"'s body and separated from the external device by tissue to enable the external device to be located in a desired position relative to the implanted device, comprising the steps of:

(a) producing a magnetic field at a defined position on one of the external device and the implanted device;

(b) sensing the magnetic field at a defined position on the other of the external device and the implanted device, and in response thereto, producing a signal indicative of a strength of the magnetic field at the defined position on said other of the external device and the implanted device;

(c) displaying an indication of the strength of the magnetic field sensed as the external device is moved relative to the implanted device, said indication enabling the external device to be located in the desired position relative to the implanted device;

(d) producing another magnetic field at a different defined position on said one of the external device and the implanted device;

(e) sensing the other magnetic field at a different defined position on said other of the external device and the implanted device and producing another signal indicative of the strength of the other magnetic field at the different defined position; and

(f) providing an indication of a relative alignment and orientation of the external device and the implanted device as a function of the signal produced at each position on the other of the external device and implanted device as the external device is moved to the implanted device.

17. The method of claim 16, further providing a visual indication of the relative strength of the magnetic field using a plurality of light sources, at least one of which is selectively energized as a function of the signal.

18. The method of claim 16, further providing an audible indication of the relative strength of the magnetic field by varying a characteristic of an audible signal as a function of the signal.

19. The method of claim 16, further providing a visual indication of the relative strength of the magnetic field sensed at each position by energizing selected light sources in an array of light sources, a disposition of each light source that is energized indicating the relative strength of the magnetic field at each position where the magnetic field is sensed.

20. The method of claim 19, wherein the array of light sources is divided into two sections, a disposition of an energized light source in each section indicating the relative strength of the magnetic field at a different one of the positions where the magnetic field is sensed.

21. The method of claim 16, further providing colored light sources that are energized to provide a visual indication of the relative strength of the magnetic field at each location, and selecting a color of the light sources that are energized as a function of the signal at each position.

22. The method of claim 16, further providing a plurality of magnetic field sensors, each magnetic field sensor comprising one of a Hall sensor and a magneto resistive sensor, said plurality of magnetic field sensors being disposed at spaced-apart positions on the external device, and sensing the magnetic field with said plurality of magnetic field sensors.

23. The method of claim 16, wherein the magnetic field is produced at each position using permanent magnets that are disposed in spaced-apart positions on the implanted device.

24. The method of claim 16, further comprising the steps of:

(a) producing a magnetic field at a specified position on said one of the external device and the implanted device that is substantially spaced apart from a line through the defined positions at which the other magnetic fields are produced;

(b) sensing the magnetic field at a specified position on the other of the external device and the implanted device at a specified position that is substantially spaced apart from a line through the defined positions at which the other magnetic fields are sensed and generally corresponding to the specified position at which the magnetic field is produced; and

(c) displaying an indication of the strength of the magnetic field sensed at the specified position determinative of a tilt of the external device relative to the implanted device, said indication enabling the external device to be located in the desired position and in alignment with the implanted device.

25. The method of claim 16, further providing that the signals produced by sensing the magnetic field at each position indicate a distance separating the external device and the implanted device.

26. A method for determining a misalignment of an external transmitter relative to an implanted internal receiver that is separated from the external transmitter by a layer of tissue, comprising the steps of:

(a) producing a magnetic field at each of two disparate locations on the implanted internal receiver;

(b) sensing the magnetic field produced at each of the two disparate positions on the implanted internal receiver at two corresponding positions on the external transmitter and producing signals indicative of a strength of the magnetic field at each of the two corresponding positions; and

(c) in response to the signals at each of the two corresponding positions on the external transmitter, providing an indication of the orientation and the position of the external transmitter as it is moved about relative to the implanted internal receiver, thereby enabling the external transmitter to be positioned opposite to and aligned with the implanted internal receiver.

27. The method of claim 26, wherein the step of providing an indication comprises the step of providing two indicators that separately represent the relative magnetic field strength at the two positions on the external transmitter.

28. The method of claim 26, wherein the step of providing an indication comprises the step of providing a plurality of light sources arranged in an array having two sections, a selected light source in each section being energized to indicate the relative alignment of a different one of the two disparate locations on the implanted internal receiver with a different one of the two disparate positions on the external transmitter.

29. The method of claim 28, wherein a disposition of the light source that is energized in each section indicates the relative magnetic field strength at one of the disparate positions.

30. The method of claim 28, wherein a color of the light source that is energized in each section indicates the relative magnetic field strength at one of the disparate positions.

31. The method of claim 26, further providing two different characteristics of an audible signal to indicate the orientation and the position of the external transmitter as it is moved about relative to the implanted internal receiver, each characteristic being associated with a different one of the signals.

32. The method of claim 26, further comprising the step of providing an indication of a distance separating the external transmitter from the implanted internal receiver.

33. The method of claim 26, further comprising the steps of:

(a) producing a magnetic field at a third location on the implanted internal receiver, said third location being substantially spaced apart from a line through said two disparate locations on the implanted internal receiver;

(b) sensing the magnetic field produced at the third location on the implanted internal receiver at a third location on the external transmitter, said third location on the external transmitter being substantially spaced apart from a line through said two corresponding locations at which the magnetic fields are sensed, and producing a signal indicative of a strength of the magnetic field produced at the third location on the implanted internal receiver, said third location on the external transmitter corresponding to the third location on the implanted internal receiver; and

(c) in response to the signal produced by sensing the magnetic field at the third location on the external transmitter, providing an indication of tilt of the external transmitter relative to the implanted internal receiver, said indication in combination with the indication of the orientation and the position provided at each of the two corresponding positions on the external transmitter be used for aligning the external transmitter with the implanted internal receiver along orthogonal axes.

34. A method for determining an alignment between an external device and an implanted device, comprising the steps of:

(a) producing a magnetic field at a first position on one of the external device and the implanted device;

(b) sensing the magnetic field at a first position on the other of the external device and the implanted device, and in response thereto, producing a signal indicative of a strength of the magnetic field at the first position on said other of the external device and the implanted device;

(c) providing an indication of the strength of the magnetic field sensed at the first position on said other of the external device and the implanted device as a function of the signal and thereby, an indication of the distance between the external device and the implanted device;

(d) producing a magnetic field at a second position on said one of the external device and the implanted device, said second position being spaced apart from the first position;

(e) sensing the magnetic field at a second position on said other of the external device and the implanted device and producing a signal indicative thereof, said second position being spaced apart from the first position on said other of the external device and implanted device and corresponding to the second position on said one of the external device and implanted device; and

(f) providing an indication of the alignment of the external device and the implanted device, and the distance between the external device and the implanted device as a function of the signals produced by sensing the magnetic field at said first and second positions on said other of the external device and the implanted device.

35. The method of claim 34, wherein the step of providing an indication comprises the step of displaying a visually perceptible indicator of the magnetic field sensed at the first position, said visually perceptible indicator changing to indicate a range of relative magnetic field strength sensed at the first position on said other of the external device and the implanted device relative to the distance between said external device and said implanted device.

36. Apparatus for determining a distance and an alignment between an external device and an implanted device, comprising:

(a) a first magnet disposed at a first position on one of the external device and the implanted device;

(b) a first magnetic field sensor disposed at a first position on the other of the external device and the implanted device, said first magnetic field sensor producing a signal indicative of a magnetic field strength;

(c) a first indicator coupled to the first magnetic field sensor, said first indicator producing a signal indicative of the strength of the magnetic field sensed by the first magnetic field sensor, said first indicator also indicating the distance between the external device and the implanted device as a function of said signal;

(d) a second magnet disposed on said one of the external device and the implanted device and spaced apart from the first magnet;

(e) a second magnetic field sensor disposed at a second position on the other of the external device and the implanted device and spaced apart from the first position disposed thereon, said second magnetic field sensor producing a signal indicative of a magnetic field strength sensed by the second magnetic field sensor; and

(f) a second indicator coupled to the second magnetic field sensor, said second indicator producing a signal indicative of the strength of the magnetic field sensed by the second magnetic field sensor, and of the distance between the external device and the implanted device as a function of said signal produced by said second magnetic field sensor, said first and second indicators together indicating when the external device is aligned with the implanted device.

37. The apparatus of claim 36, wherein the first indicator is a visual indicator that includes a visual display indicative of a relative magnetic field strength and of the distance between the external device and the implanted device.

38. The apparatus of claim 36, wherein the first magnetic field sensor comprises one of a Hall effect sensor and a magneto resistive sensor.

39. Apparatus for transmitting energy from an external transmitter to an implanted receiver, by determining a position of the external transmitter relative to the implanted receiver, which is separated from the external transmitter by tissue, to enable said external transmitter to be aligned with the implanted receiver, to increase an efficiency with which the energy is transmitted, comprising:

(a) a magnet disposed on one of the external transmitter and the implanted receiver;

(b) a magnetic field sensor disposed on another of the external transmitter and the implanted receiver, said magnetic field sensor producing a signal indicative of a magnetic field strength; and

(c) an indicator coupled to the magnetic field sensor to receive the signal, said indicator providing an indication of the position of the external transmitter relative to the implanted receiver as a function of the magnetic field strength sensed by the magnetic field sensor as said external transmitter is moved adjacent to the implanted receiver, so that said external transmitter can be aligned with said implanted receiver.

40. Apparatus for transmitting energy from an external transmitter to an implanted receiver, by determining a position of the external transmitter relative to the implanted receiver, which is separated from the external transmitter by tissue, and to enable said external transmitter to be aligned with the implanted receiver, in order to increase an efficiency with which the energy is transmitted, comprising:

(a) a magnet disposed on one of the external transmitter and the implanted receiver;

(b) a magnetic field sensor disposed on another of the external transmitter and the implanted receiver, said magnetic field sensor producing a signal indicative of a magnetic field strength;

(c) an indicator coupled to the magnetic field sensor to receive the signal, said indicator providing an indication of the position of the external transmitter relative to the implanted receiver as a function of the magnetic field strength sensed by the magnetic field sensor as said external transmitter is moved adjacent to the implanted receiver, so that said external transmitter can be aligned with said implanted receiver;

(d) another magnet disposed on said one of the external transmitter and the implanted receiver;

(e) another magnetic field sensor disposed on said other of the external transmitter and the implanted receiver, said other magnetic field sensor producing another signal indicative of a magnetic field strength; and

(f) another indicator coupled to the other magnetic field sensor to receive the other signal, said other indicator providing an indication of the position and orientation of the external transmitter relative to the implanted receiver as a function of the magnetic field strength sensed by the other magnetic field sensor as said external transmitter is moved adjacent to the implanted receiver and thereby enabling the external transmitter to be aligned with the implanted receiver so as to most efficiently transfer energy to the implanted receiver from the external transmitter.

41. The apparatus of claim 40, wherein each of the magnetic field sensors comprises one of a Hall effect sensor and a magneto resistive sensor.

42. The apparatus of claim 40, wherein the magnetic field sensors are disposed at spaced-apart locations on the external transmitter.

43. The apparatus of claim 40, wherein the magnets are disposed at spaced-apart locations on the implanted receiver.

44. The apparatus of claim 40, wherein each of the indicators comprises a plurality of light sources and a driver circuit coupled to receive the signal, said driver circuit selectively energizing specific ones of the light sources as an indication of the field strength, and thus, of the position of the external transmitter relative to the implanted receiver.

45. A method for increasing the efficiency of the transcutaneous transmission of energy from an external transmitter to an implanted receiver, comprising the steps of:

(a) locating the external transmitter adjacent the implanted receiver by;

(i) producing a magnetic field at a first position on one of the external device and the implanted receiver;

(ii) sensing the magnetic field at a first position on another of the external transmitter and the implanted receiver, and in response thereto, producing a signal indicative of a strength of the magnetic field at the first position on said other of the external transmitter and the implanted receiver; and

(iii) providing an indication of the strength of the magnetic field sensed at the first position on said other of the external transmitter and the implanted receiver as a function of the signal and thereby, an indication of the distance between the external transmitter and the implanted receiver;

(b) energizing the external transmitter for a length of time required to transfer a desired amount of energy to the implanted receiver;

(c) producing a magnetic field at a second position on said one of the external transmitter and the implanted receiver, said second position being spaced apart from the first position;

(d) sensing the magnetic field at a second position on said other of the external transmitter and the implanted receiver and producing a signal indicative thereof, said second position being spaced apart from the first position on said other of the external transmitter and implanted receiver and corresponding to the second position on said one of the external transmitter and implanted receiver; and

(e) providing an indication of the alignment of the external transmitter and the implanted receiver, and the distance between the external transmitter and the implanted receiver as a function of the signals produced by sensing the magnetic field at said first and second positions on said other of the external transmitter and the implanted receiver.

46. The method of claim 45, wherein each of the steps of providing an indication comprises the step of displaying a visually perceptible indicator of the magnetic field sensed at one of the first position and the second position, said visually perceptible indicator indicating a range of relative magnetic field strength sensed at one of the first position and the second position on said other of the external transmitter and the implanted receiver relative to the distance between said external transmitter and said implanted receiver.