Ultrasound Guided Probe Device and Sterilizable Shield for Same

• US 20110087105A1
• Filed: 10/09/2009
• Published: 04/14/2011
• Est. Priority Date: 10/09/2009
• Status: Active Grant

• Current Assignee: Soma Research, LLC
• Original Assignee: Soma Development LLC
• Inventors: Ridley, Stephen F., Hagy, M. Dexter
• Granted Patent: US 8,761,862 B2
• Time in Patent Office: Days
• US Class Current: 600/459
• CPC Class Codes: A61B 1/00142 with means for preventing contamination, e.g. by using a sanitary sheath
• 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 2017/00296 mounted on an endoscope
• CPC Class Codes: A61B 2017/00858 high friction, non-slip on handles A61B2017/00429
• CPC Class Codes: A61B 2017/3405 using mechanical guide means
• CPC Class Codes: A61B 2017/3413 guided by ultrasound
• CPC Class Codes: A61B 46/10 specially adapted for instruments, e.g. microscopes
• 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 8/4209 by using holders, e.g. positioning frames
• CPC Class Codes: A61B 8/4254 using sensors mounted on the probe
• CPC Class Codes: A61B 8/4281 characterised by sound-transmitting media or devices for coupling the transducer to the tissue
• CPC Class Codes: A61B 8/4422 related to hygiene or sterilisation
• CPC Class Codes: A61B 8/461 Displaying means of special interest

Abstract

Disclosed are medical probe devices and methods for use guiding of percutaneous probes during medical procedures. The probe devices include an ultrasound transducer housing having a passage therethrough configured to accommodate a probe. The devices can be utilized to guide a probe through the probe guide to a percutaneous target with real time visualization of the probe during the procedure. In addition, the devices can include a sterilizable shield including a sterile probe guide such that the transducer housing itself can be separated from a subject by a sterile barrier. The sterilizable shield can be a single-use shield that can prevent contamination and re-use of the shield. The devices can define a beneficial geometry conducive to use by a single operator that can be utilized for percutaneous targets near the skin surface and can enable excellent contact between the device and the skin surface of a subject.

Claims

1. A medical probe device comprising a skin contacting surface, the skin contacting surface comprising a first portion defining a first plane and a second portion defining a second plane, the first plane and the second plane intersecting one another to define an angle therebetween that is greater than about 150°

and less than 180°

, the first portion defining a probe guide therethrough, the second portion being associated with an ultrasound transducer such that an ultrasonic beam transmitted from said ultrasound transducer issues from said second portion.

2. The medical probe device of claim 1, wherein the first portion and the second portion are contiguous to one another.

3. The medical probe device of claim 1, wherein the first portion and the second portion are removably attachable to one another.

4. The medical probe device of claim 1, wherein the first portion is a surface of an ultrasound transducer housing.

5. The medical probe device of claim 1, wherein the first portion is a surface of a probe guide portion and the second portion is a surface of a sterilizable shield.

6. The medical probe device of claim 1, further comprising a clamp for clamping a probe in the probe guide.

7. The medical probe device of claim 1, wherein at least one of the first portion and the second portion defines an arcuate profile.

8. The medical probe device of claim 1, wherein the ultrasound transducer is connectable to a monitor for displaying a sonogram.

9. The medical probe device of claim 8, wherein the path of a probe guided through the probe guide defines a line that is within the scanned plane of the sonogram.

10. The medical probe device of claim 8, further comprising a detector for detecting motion of a probe within the probe guide, the detector being in communication with a processor for displaying information concerning the motion of the probe within the probe guide.

11. The medical probe device of claim 10, wherein the information is displayed as an image of a virtual probe on the monitor.

12. A medical probe device comprising a skin contacting surface, the skin contacting surface defining a probe guide therethrough, the skin contacting surface being associated with an ultrasound transducer such that an ultrasonic beam transmitted from said ultrasound transducer issues from said skin contacting surface, said medical probe device further comprising at least one raised ridge on said skin contacting surface.

13. The medical probe device of claim 12, wherein the skin contacting surface comprises a first portion defining the probe guide and comprises a second portion from which said ultrasonic beam issues.

14. The medical probe device of claim 13, wherein the first portion defines a first plane and the second portion defines a second plane, the first plane and the second plane intersecting one another to define an angle therebetween that is greater than about 150°

and less than 180°

.

15. The medical probe device of claim 13, wherein the first portion and the second portion are removably attachable to one another.

16. The medical probe device of claim 12, wherein the skin contacting surface is a surface of an ultrasound transducer housing.

17. The medical probe device of claim 12, wherein the skin contacting surface is a surface of a sterilizable shield.

18. The medical probe device of claim 12, further comprising a clamp for clamping a probe in the probe guide.

19. The medical probe device of claim 12, wherein the ultrasound transducer is connectable to a monitor for displaying a sonogram.

20. The medical probe device of claim 19, wherein the path of a probe guided through the probe guide defines a line that is within the scanned plane of the sonogram.

21. The medical probe device of claim 19, further comprising a detector for detecting motion of a probe within the probe guide, the detector being in communication with a processor for displaying information concerning the motion of the probe within the probe guide.

22. The medical probe device of claim 21, wherein the information is displayed as an image of a virtual probe on the monitor.

23. The medical probe device of claim 12, wherein the raised ridge is formed of the same material as at least a portion of the skin contacting surface.

24. The medical probe device of claim 12, wherein the raised ridge is formed of a different material than at least a portion of the skin contacting surface.

25. A single-use sterilizable shield comprising a first section, a second section and a fastener for connecting the first section and the second section to one another, wherein the fastener is a single-use fastener that is permanently disabled upon disconnection and separation of the first section and the second section from one another, the single-use sterilizable shield comprising a skin contacting surface that defines a probe guide therethrough for passage of a probe, the probe guide providing an unimpeded passageway through the shield.

26. The single-use sterilizable shield of claim 25, wherein the probe guide is adapted for receipt in a probe guide opening defined by an ultrasound transducer housing.

27. The single-use sterilizable shield of claim 25, wherein the skin contacting surface comprises a first portion defining a first plane and a second portion defining a second plane, the first portion and the second portion being contiguous, the first plane and the second plane intersecting one another to define an angle therebetween that is greater than about 150°

and less than 180°

, the first portion defining the probe guide therethrough, the second portion being adapted to conform to the base of an ultrasound transducer housing such that an ultrasonic beam transmitted from an ultrasound transducer held within the ultrasound transducer housing issues from said second portion.

28. The single-use sterilizable shield of claim 25, the sterilizable shield further comprising at least one raised ridge on said skin contacting surface.

29. The single-use sterilizable shield of claim 25, the sterilizable shield further comprising a clamp for clamping a probe in the probe guide.

30. The single-use sterilizable shield of claim 25, the sterilizable shield being removably attachable to an ultrasound transducer housing.

31. A method for guiding a probe to a percutaneous target comprising:

seating an ultrasound transducer housing within a first section of a sterilizable shield, the ultrasound transducer housing including an ultrasound transducer for transmitting an ultrasonic beam and receiving reflections of the ultrasonic beam;

aligning a second section of the sterilizable shield with the first section of the sterilizable shield, wherein the second section of the sterilizable shield encloses a portion of the ultrasound transducer housing;

fastening the first and second sections of the sterilizable shield to one another by use of a single-use fastener to enclose at least that portion of the ultrasound transducer housing that includes the ultrasound transducer within the sterilizable shield;

guiding a probe defining a probe tip such that the probe tip arrives at the percutaneous target; and

disassembling the first section and the second section from one another, wherein the single-use fastener is permanently disabled upon the disassembly.

32. The method according to claim 31, wherein the sterilizable shield defines a probe guide.

33. The method according to claim 32, wherein the ultrasound transducer housing defines a probe guide opening, the probe guide being received into the probe guide opening upon seating the ultrasound transducer housing within the first section of the sterilizable shield.

34. The method according to claim 33, wherein the probe guide is completely surrounded by the probe guide opening along the length of the probe guide following fastening of the first and second sections of the sterilizable shield to one another.

35. The method according to claim 31, further comprising clamping the probe in the probe guide when the probe tip is at the percutaneous target.

36. The method according to claim 31, further comprising transmitting an ultrasonic beam from the transducer assembly, and forming a sonogram of the percutaneous target in response to the reflections of the ultrasonic beam.

37. The method according to claim 36, further comprising forming a virtual image of the probe on the sonogram.

38. A method for guiding a probe to a percutaneous target comprising:

locating a skin contacting surface of a probe device on a skin surface, the probe device including an ultrasound transducer for transmitting an ultrasonic beam and receiving reflections of the ultrasonic beam, the skin contacting surface of the probe device comprising a first portion defining a first plane and a second portion defining a second plane, the first plane and the second plane intersecting one another to define an angle therebetween that is greater than about 150° and

less than 180°

, the first portion defining a probe guide therethrough, the second portion being associated with the ultrasound transducer such that the ultrasonic beam transmitted from said ultrasound transducer issues from the second portion;

transmitting the ultrasonic beam from the ultrasound transducer and forming a sonogram of the percutaneous target in response to the reflections of the ultrasonic beam; and

guiding a probe through the probe guide opening such that the probe tip travels from the skin surface, enters the scanned plane of the sonogram, and arrives at the percutaneous target, wherein the distance traveled by the probe from the skin surface to the entrance of the ultrasonic beam is less than about 25 mm.

39. The method according to claim 38, wherein the first portion and the second portion are contiguous.

40. The method according to claim 38, wherein the first portion and the second portion are removably attachable to one another.

41. The method according to claim 38, further comprising clamping the probe in the probe guide when the probe tip is at the percutaneous target.

42. The method according to claim 38, further comprising forming a virtual image of the probe on the sonogram.

43. A medical probe device comprising

a first portion comprising an ultrasound transducer housing;

a second portion, the second portion defining at least a portion of a probe guide for passage of a probe therethrough, the probe guide providing an unimpeded passageway through the medical probe device, the second portion being removably attachable to the first portion;

a detector for detecting motion of a probe within the probe guide, the detector being in communication with a processor for displaying information concerning the motion or position of the probe within the probe guide.

44. The medical probe device of claim 43, further comprising a sterilizable shield for encasing at least a portion of the device.

45. The medical probe device of claim 44, the first portion defining a first surface, the ultrasound transducer being located in the first portion such that an ultrasonic beam issued from the ultrasound transducer is emitted from the first surface, wherein the sterilizable shield encases the first surface of the first portion and remaining surfaces of the first portion are not encased by the sterilizable shield.

46. The medical probe device of claim 44, wherein the sterilizable shield encases the entire first portion, the second portion being directly or indirectly removably attachable to the sterilizable shield.

47. The medical probe device of claim 43, the first portion defining a skin contacting surface, wherein the second portion does not contact the skin of a subject when the skin contacting surface of the first portion is in contact with the subject'"'"'s skin.

48. The medical probe device of claim 43, wherein the information is displayed as an image of a virtual probe on a monitor in communication with the processor.

49. The medical probe device of claim 43, wherein the sensor is integral to the first portion.

50. The medical probe device of claim 43, wherein a portion of the probe guide is defined by the first portion and a portion of the probe guide is defined by the second portion.

51. The medical probe device of claim 43, wherein the entire probe guide is defined by the second portion.

52. The medical probe device of claim 43, wherein the second portion is sterile.

53. The medical probe device of claim 43, wherein the second portion comprises multiple removably attachable pieces.

54. The medical probe device of claim 53, wherein one of the removably attachable pieces is a clamp.

55. A method for guiding a probe to a percutaneous target comprising

attaching a first portion of a medical probe device to a second portion of the medical probe device, the first portion comprising an ultrasound transducer housing and the second portion defining at least a portion of a probe guide for passage of a probe therethrough, the probe guide providing an unimpeded passageway through the medical probe device, the second portion being removably attachable to the first portion;

passing a probe through the probe guide to a percutaneous target;

detecting motion of the probe within the probe guide, the detector being in communication with a processor; and

displaying information concerning the motion or position of the probe within the probe guide.

56. The method of claim 55, further comprising encasing at least a portion of the device with a sterilizable shield.

57. The method of claim 55, wherein the second portion does not contact the skin of a subject during use and the probe exits the probe guide at a distance from the skin of the subject.

58. The method of claim 55, further comprising forming an image of a virtual probe on a monitor in communication with the processor.

59. The method of claim 55, wherein the complete probe guide is formed only upon attachment of the first portion to the second portion.

60. The method of claim 55, wherein the second portion is sterile.

61. The method of claim 55, further comprising combining multiple removably attachable pieces to form the second portion.

62. The method of claim 55, further comprising clamping the probe in the probe guide when the probe guide is at the percutaneous target.