Guide and position monitor for invasive medical instrument

• US 6,695,786 B2
• Filed: 03/18/2002
• Issued: 02/24/2004
• Est. Priority Date: 03/16/2001
• Status: Expired due to Term

• Current Assignee: U-System Inc. (General Electric Company)
• Original Assignee: U-System Inc. (General Electric Company)
• Inventors: Wang, Shih-Ping, Lin, Shengtz, Zhang, Siqing, Chin, Donald, Maroc, Karen D.
• Primary Examiner(s): Ruhl, Dennis
• Assistant Examiner(s): Jung, William C.
• Application Number:
  US10/100,649
• Publication Number:
  US 20020156376A1
• Time in Patent Office: 708 Days
• Field of Search: 600/407-472
• US Class Current: 600/461
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 2017/3405 using mechanical guide means
• CPC Class Codes: A61B 2017/3411 with a plurality of holes, e.g. holes in matrix arrangement
• CPC Class Codes: A61B 2017/3413 guided by ultrasound
• CPC Class Codes: A61B 34/72 Micromanipulators
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/587 Calibration phantoms models for medical purposes G09B23/28
• CPC Class Codes: A61B 90/50 Supports for surgical instruments, e.g. articulated arms

Abstract

An instrument guide is described for mounting an invasive instrument such as a biopsy needle to an imaging probe, controlling its position, monitoring its position, and/or predictively displaying its position on a user display of the medical imaging system. A plurality of substantially rigid segments are hingeably connected to the probe, to an instrument handle, and to each other such that movement of the biopsy needle is restricted to within the imaged plane. However, substantial freedom of movement within the imaged plane is provided such that the instrument may be inserted into the patient over a wide range of angles. In one preferred embodiment, angle detectors are provided at each segment intersection and measurements provided for computing and displaying the instrument position and orientation on the user display. The instrument guide/position monitor is preferably made with low-cost components such that it is disposable after a single use. A predictive user display is provided in which the throw of a spring-loaded instrument is shown on the user display, the throw corresponding to the space that the instrument will occupy after a spring trigger is activated.

Claims

1. An apparatus for coupling an invasive medical instrument to an imaging probe, the imaging probe having a substantially planar scanning field, comprising;

a substantially rigid first link member that hingeably couples to the imaging probe such that relative movement of said first link member and the imaging probe is restricted around a first hinge axis substantially perpendicular to the scanning field plane;

a substantially rigid second link member that hingeably couples to the medical instrument such that relative movement of said second link member and the medical instrument is restricted around a second hinge axis substantially perpendicular to the scanning field plane; and

at least one substantially rigid intermediate link member hingeably coupled in a serial manner between said first and second link members, said apparatus substantially confining movement of the medical instrument to the scanning field plane while permitting movement of the medical instrument within that plane from a first orientation parallel to an axis of the imaging probe to a second orientation perpendicular to the axis of the imaging probe.

2. The apparatus of claim 1, further comprising a probe collar that fixably attaches to the imaging probe, said probe collar being hingeably coupled to said first link member to achieve said hingeable coupling of said first link member to the imaging probe.

3. The apparatus of claim 1, further comprising a handle that fixably attaches to the medical instrument, said handle being hingeably coupled to said second link member to achieve said hingeable coupling of said second link member to the medical instrument.

4. The apparatus of claim 1, wherein the number of intermediate link members is two.

5. The apparatus of claim 4, said first link member, said second link member, and said two intermediate link members being configured and dimensioned such that movement of the medical instrument within the scanning field plane selectively includes a third orientation 135 degrees from the axis of the imaging probe.

6. The apparatus of claim 5, said first link member, said second link member, and said two intermediate link members being configured and dimensioned such that movement of the medical instrument within the scanning field plane selectively includes a fourth orientation 180 degrees from the axis of the imaging probe.

7. The apparatus of claim 1, wherein there are at least four of said intermediate link members serially and hingeably coupled between said first and second link members.

8. The apparatus of claim 1, said intermediate link members being hingeably coupled between said first and second link members such that movement between any two adjacent link members is restricted around a hinge axis therebetween substantially perpendicular to the scanning field plane.

9. The apparatus of claim 8, wherein each of said link members comprises a rigid plastic material and is hingeably coupled to adjacent link members by a pin-in-slot hinge.

10. The apparatus of claim 8, wherein each of said link members comprises a rigid plastic material, and wherein adjacent link members are hingeably coupled using living hinges.

11. The apparatus of claim 10, wherein said link members are formed from a common sheet of low-cost plastic material into which grooves are cut to form said living hinges.

12. The apparatus of claim 1, further comprising a plurality of angle detectors, one for each of said hingeable couplings, for detecting current angles (i) between said imaging probe and said first link member, (ii) between adjacent first, intermediate, and second link members, and (iii) between said second link member and said medical instrument, respectively, and for communicating the current angles to an external computing device, the external computing device computing a current position of the medical instrument with respect to the imaging probe based on said current angles.

13. The apparatus of claim 12, wherein each angle detector between adjacent link members detects the current angle therebetween based on an inductive coupling effect that varies with the current angle.

14. The apparatus of claim 12, wherein each angle detector between adjacent link members comprises a potentiometer.

15. The apparatus of claim 14, wherein said potentiometer is affixed to its associated link members such that it also serves as said hingeable coupling therebetween.

16. The apparatus of claim 15, said potentiometer yielding a resistance reading according to an angle between first and second mechanical portions thereof, wherein said first mechanical portion is affixed to one of said associated link members and said second mechanical portion is affixed to the other.

17. The apparatus of claim 12, wherein said current angles between link members are communicated to the external computing device over an electric ribbon cable.

18. The apparatus of claim 12, wherein said current angles between link members are communicated to the external computing device using transmitters selected from the group consisting of:

optical transmitters, infrared transmitters, radio transmitters, electromagnetic signal transmitters, and acoustic transmitters.

19. The apparatus of claim 12, the imaging probe being associated with a user display of an imaged portion of a subject patient, further comprising a computer program product associated with said external computing device, comprising:

computer code for receiving said current angles;

computer code for computing a current position of the medical instrument relative to the imaging probe using said current angles; and

computer code for displaying a representation of the medical instrument on the user display for locations of overlap between the imaged portion and the medical instrument.

20. The apparatus of claim 19, further comprising computer code for predictively projecting the medical instrument onto the imaged portion based on the current position and orientation of the medical instrument relative to the imaging probe.

48. The apparatus of claim 1, wherein the number of intermediate link members is three.

21. A biopsy guide for use in controlling the position of a biopsy needle relative to an ultrasound probe during an ultrasound-assisted biopsy procedure, the ultrasound probe scanning a patient along an imaged plane, comprising:

a first connector for fixable attachment to the ultrasound probe;

a second connector for fixable attachment to a handle of the biopsy needle; and

a link assembly comprising at least three substantially rigid members hingeably connected to each other, said link assembly being hingeably connected to said first connector at one end and hingeably connected to said second connector at another end such that movement of the biopsy needle is substantially restricted to the imaged plane.

22. The biopsy guide of claim 21, wherein said link assembly comprises at least four substantially rigid members.

23. The biopsy guide of claim 21, wherein said link assembly comprises at least five substantially rigid members.

24. The biopsy guide of claim 21, said link assembly being configured and dimensioned such that the biopsy needle selectively moves within the imaged plane from a first orientation parallel to an axis of the ultrasound probe to a second orientation perpendicular to the axis of the imaging probe.

25. The biopsy guide of claim 24, said link assembly comprising at least five substantially rigid members configured and dimensioned such that the biopsy needle selectively enters a patient up to 10 cm away from the ultrasound probe at any angle between said first and second orientations in the imaged plane.

26. The biopsy guide of claim 24, said link assembly being configured and dimensioned such that the biopsy needle selectively moves within the imaged plane up to a third orientation 180 degrees from the axis of the imaging probe.

27. The biopsy guide of claim 21, wherein each link assembly member comprises a rigid plastic material and is hingeably coupled to adjacent link assembly members by a pin-in-slot hinge.

28. The biopsy guide of claim 21, wherein each link assembly member comprises a rigid plastic material, and wherein adjacent link assembly members are hingeably coupled using living hinges.

29. The biopsy guide of claim 28, wherein said link assembly members are formed from a common sheet of low-cost plastic material into which grooves are cut to form said living hinges, whereby said biopsy guide is low-cost and disposable.

30. The biopsy guide of claim 21, further comprising a plurality of angle detectors, one for each of said hingeable couplings, for detecting current angles (i) between said first connector and a first link assembly member, (ii) between adjacent link assembly members, and (iii) between a final link assembly member and said second connector, respectively, and for communicating the current angles to the ultrasound system associated with the ultrasound probe, the ultrasound system computing a current position of the biopsy needle with respect to the ultrasound probe based on said current angles.

31. The biopsy guide of claim 30, wherein each angle detector between adjacent link assembly members detects the current angle therebetween based on an inductive coupling effect that varies with the current angle.

32. The biopsy guide of claim 30, wherein each angle detector between adjacent link assembly members comprises a potentiometer.

33. The biopsy guide of claim 32, wherein said potentiometer is affixed to its associated link assembly members such that it also serves as said hingeable coupling therebetween.

34. The biopsy guide of claim 32, wherein said current angles between link members are communicated to the ultrasound system by one or more of the following methods:

electrical transmission over ribbon cables;

optical transmission, infrared transmission, radio transmission, electromagnetic signal transmission, and acoustic transmission.

35. The biopsy guide of claim 30, the ultrasound system displaying the imaged plane on a user display according to the current plane being scanned by the ultrasound probe, further comprising a computer program product associated therewith, comprising:

computer code for receiving said current angles;

computer code for computing a current position of the biopsy needle relative to the ultrasound probe using said current angles; and

computer code for displaying a representation of the biopsy needle on the user display for locations of overlap between the imaged plane and the biopsy needle.

36. The biopsy guide of claim 35, further comprising computer code for predictively projecting the biopsy needle onto the user display based on the current position and orientation of the biopsy needle relative to the ultrasound probe.

37. An apparatus for use in an ultrasound-guided biopsy procedure in which a biopsy needle is inserted into a patient while an ultrasound probe scans the patient along an imaged plane, comprising:

a link assembly comprising a plurality of substantially rigid link members, said link assembly being configured for hingeable attachment to the ultrasound probe at one end and for hingeable attachment to the biopsy needle at the other end such that movement of the biopsy needle is restricted to the imaged plane; and

a plurality of position encoders respectively positioned at each interface between adjacent ones of said link members, between a first of said link members and the ultrasound probe, and between a last of said link members and the biopsy needle for detecting and providing relative position information such that a current position of the biopsy needle relative to the ultrasound probe can be computed.

38. The apparatus of claim 37, said position encoders providing said relative position information to an ultrasound system associated with said ultrasound probe.

39. The apparatus of claim 38, the ultrasound system having a user display that displays the imaged plane of the patient, further comprising a computer program product for use by the ultrasound system, the computer program product comprising:

computer code for receiving said relative position information;

computer code for computing said current position of the biopsy needle relative to the ultrasound probe using said relative position information; and

computer code for displaying a representation of the biopsy needle on the user display for locations of overlap between the imaged plane and the biopsy needle.

40. The apparatus of claim 39, further comprising computer code for predictively projecting the biopsy needle onto the user display based on the current position and orientation of the biopsy needle relative to the ultrasound probe.

41. The apparatus of claim 37, said link members being hingeably attached to each other, said position encoders between said link members being angle detectors.

42. The apparatus of claim 41, said link assembly comprising at least four link members, said link assembly being configured and dimensioned such that the biopsy needle selectively moves within the imaged plane from a first orientation parallel to an axis of the ultrasound probe to a second orientation perpendicular to the axis of the imaging probe.

43. The apparatus of claim 42, said link assembly comprising at least five link members configured and dimensioned such that the biopsy needle selectively enters a patient up to 10 cm away from the ultrasound probe at any angle between said first and second orientations within the imaged plane.

44. The apparatus of claim 42, said link assembly being configured and dimensioned such that the biopsy needle selectively moves within the imaged plane up to a third orientation 180 degrees from the axis of the imaging probe.

45. The apparatus of claim 42, wherein each link member comprises a rigid plastic material and is hingeably coupled to adjacent link members by a pin-in-slot hinge.

46. The apparatus of claim 42, wherein each link member comprises a rigid plastic material, and wherein adjacent link members are hingeably coupled using living hinges.

47. The apparatus of claim 46, wherein said link members are formed from a common sheet of low-cost plastic material into which grooves are cut to form said living hinges, whereby said biopsy guide is low-cost and disposable.