Guide and position monitor for invasive medical instrument

• US 20020156376A1
• Filed: 03/18/2002
• Published: 10/24/2002
• Est. Priority Date: 03/16/2001
• Status: Active Grant

• Current Assignee: U-System Inc. (General Electric Company)
• Original Assignee: U-System Inc. (General Electric Company)
• Inventors: Maroc, Karen D., Zhang, Siqing, Wang, Shih-Ping, Lin, Shengtz, Chin, Donald
• Granted Patent: US 6,695,786 B2
• Time in Patent Office: Days
• US Class Current: 600/439
• 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

For use in medical procedures such as ultrasound-assisted biopsies in which an invasive medical instrument such as a biopsy needle is guided by a medical imaging system such as an ultrasound system, an instrument guide is described for mounting the instrument 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 provided to the medical imaging system for computing and displaying the position and orientation of the instrument 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. In another preferred embodiment, 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

5-1. 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 eon 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.

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.

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.