REGISTRATION DEVICE, SYSTEM, KIT AND METHOD FOR A PATIENT REGISTRATION

• US 20130331686A1
• Filed: 09/21/2011
• Published: 12/12/2013
• Est. Priority Date: 09/21/2010
• Status: Active Grant

• Current Assignee: Medizinische Universitã¤T Innsbruck
• Original Assignee: Medizinische Universitã¤T Innsbruck
• Inventors: Freysinger, Wolfgang, Kral, Florian
• Granted Patent: US 10,524,693 B2
• Time in Patent Office: Days
• US Class Current: 600/417
• CPC Class Codes: A61B 17/24 for use in the oral cavity, larynx, bronchial passages or nose for medical inspection of cavities or tubes in the body A61B1/00; Tongue scrapers
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/3912 Body cavities
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2090/3983 Reference marker arrangements for use with image guided surgery
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61B 2090/3991 having specific anchoring means to fixate the marker to the tissue, e.g. hooks
• CPC Class Codes: A61B 2090/3995 Multi-modality markers
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/0035 adapted for acquisition of images from more than one imaging mode, e.g. combining MRI and optical tomography
• CPC Class Codes: A61B 5/064 using markers A61B5/062 takes precedence
• CPC Class Codes: A61B 6/032 Transmission computed tomography [CT]
• CPC Class Codes: A61B 6/037 Emission tomography
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

A registration device (1) for patient registration comprises at least one reference marker (2) adapted to be sensed by an imaging system (5) and/or at least one position element (3) adapted to be localized by a position sensing system (6), and fixation means (4) for positioning the registration device (1) in a patient'"'"'s body cavity at a location comprising soft tissue. The registration device (1) is adapted to be introduced into and positioned in the patient'"'"'s body cavity, particularly in the viscerocranium such as the nasal cavity, the nasopharynx, the ear canal(s) and/or the neurocranium such as a cerebral ventricle.

Claims

1. A registration device for patient registration, wherein the registration device comprises:

at least one reference marker adapted to be sensed by an imaging system and/or at least one position element adapted to be localized by a position sensing system, and fixation means for positioning the registration device in a patient'"'"'s body cavity at a location comprising soft tissue,

wherein the registration device is adapted to be introduced into and positioned in the patient'"'"'s body cavity, particularly in the viscerocranium such as the nasal cavity, the nasopharynx, the ear canal and/or the neurocranium such as a cerebral ventricle.

2. The registration device according to claim 1, wherein the registration device has a first physical extent, preferably for facilitating introduction of the registration device in a patient'"'"'s body cavity, and a second physical extent, allowing positioning of the registration device in the patient'"'"'s body cavity by means of the fixation means.

3. The registration device according to claim 1, wherein the fixation means is adapted to position the registration device in a fixed position, preferably by clamping, in, against, and/or through the soft tissue of the patient'"'"'s body cavity.

4. The registration device according to claim 2, wherein the second physical extent is a predetermined, preferably final, shape of the registration device.

5. The registration device according to claim 1, wherein the registration device is at least partly expandable or compressible to achieve the second or first physical extent.

6. The registration device according to claim 1, wherein the fixation means comprises at least one of the following elements:

extension member, body, hollow part and/or clamping means.

7. The registration device according to claim 6, wherein the at least one extension member and/or the at least one clamping means comprises an elastic wire, a filament, an elastic coil, a rod, an arm, a leg, a clamp, and/or a foam member.

8. The registration device according to claim 6, wherein the at east one extension member has a polygonal, preferably triangular, cross-sectional shape.

9. The registration device according to claim 1, wherein the registration device comprises at least one adjustment element being adapted to urge the registration device at least partially from the first physical extent into the second physical extent.

10. The registration device according to claim 9, wherein the registration device is at least partially urged from the first physical extent into the second physical extent by moving adjustment element relative to the at least one extension member, preferably by sliding adjustment element along extension member.

11. The registration device according to claim 9, wherein a element is ring- or oval-shaped.

12. The registration device according to claim 9, wherein the at leas one adjustment element comprises at least one position element.

13. The registration device according to claim 9, wherein the at least one extension member is at least partially received and/or held by adjustment element.

14. The registration device according to claim 6, wherein the at least one extension member comprises at least one engagement portion.

15. The registration device according to claim 14, wherein the at least one engagement portion is adapted to be mounted in or on an anatomical structure.

16. The registration device according to claim 14, wherein the at least one extension member comprises:

a first extension portion being at one end thereof connected with the at least one engagement portion, and

preferably also a second extension portion being connected to the end of the first extension portion which is opposite of the engagement portion.

17. The registration device according to claim 16, wherein the registration device comprises at least two extension members, and wherein at least some of the first extension portions of the at least two extension members extend at least partially in an divergent manner thereby enveloping an inner space adapted to receive at least a part of an internal body structure, preferably soft tissue such as mucosa or meninges of the body cavity, and preferably the nasal septum.

18. The registration device according to claim 16, wherein the registration device comprises at least two extension members, and wherein at least some of the second extension portions of the at least two extension members extend at least partially in a divergent manner.

19. The registration device according to claim 16, wherein the registration device comprises at least two extension members, and

wherein at least some of the divergently extending first extension portions move at least partially in a converging manner when the at least one adjustment element is moved along the first extension portions, preferably towards the engagement portion, and/or

wherein at least some of the divergently extending second extension portions move at least partially in a converging manner when the at least one adjustment element is moved along the second extension portions, preferably towards the free end of the second extension portion.

20. The registration device according to claim 16, wherein at least some of the at least one reference marker and/or at least some of the at least one position element are located at the at least one second extension portion, preferably at or adjacent the free end of the second extension portion.

21. The registration device according to claim 9, wherein the registration device, preferably the at least one extension member, comprises a locking means, preferably being configured as a latch being adapted to reduce or avoid a movement of adjustment element relative to the at least one extension member.

22. The registration device according to claim 9, wherein at least one of the first and/or second extension portions are configured so as to be biased or preloaded by at least one adjustment element.

23. The registration device according to claim 9, wherein the adjustment element and/or the extension member is/are adapted to allow the adjustment element to be positioned at predefined positions

24. The registration device according to claim 9, wherein the at least one extension member is fixated in a precalibrated spatial configuration encoded by the fixation position of the at least one adjustment element, wherein the encoding preferably allows the determination of the relative position of the position element on the fixation means and/or on the extension member.

25. The registration device according to claim 1, wherein the registration device, preferably the extension member, comprises at least one body, wherein the body comprises a tube, a tube-shaped mesh, a grid, an expandable cushion, an inflatable balloon, a foam member and/or an inflatable hollow part.

26. The registration device according to claim 6, wherein body is substantially ring- or oval-shaped.

27. The registration device according to claim 1, wherein the registration device comprises a connecting element, to which the fixation means are mounted.

28. The registration device according to claim 27, wherein registration device comprises at least two extension members, and

wherein the at least two extension members are directly connected to each other and/or to the connection element.

29. The registration device according to claim 27, wherein the connection element substantially has an annular shape, a ring shape, a spherical shape, or an oval shape.

30. The registration device according to claim 1, wherein the registration device comprises at least one reference marker mounting and at least one position element mounting, and

wherein at least one reference marker mounting and/or at least one position element mounting is/are preferably located in the outer circumferential area of the registration device, and wherein, preferably, at least one reference marker mounting and/or at least one position element mounting is/are located at the end of at least one extension member of the registration device.

31. The registration device according to claim 1, wherein the at least one reference marker and/or at least one position element are removably attached to the registration device.

32. The registration device according to claim 1, wherein the at least one fixation means comprises at least one of clamping means, abutment member, tooth, spike, and/or thorn.

33. The registration device according to claim 1, wherein the at least one clamping means is adapted to be positioned, preferably clamped on or against, on an internal body structure, preferably soft tissue such as mucosa or meninges of the body cavity, and preferably on the nasal septum.

34. The registration device according to claim 1, wherein the registration device is provided with at least one carrier removably attached to the at least one fixation means, body, and/or connection element and/or constitutes a part thereof, the carrier preferably comprising at least one reference marker mounting, at least one position element mounting, at least one position element and/or at least one reference marker.

35. The registration device according to claim 34, wherein the at least one carrier comprises two position elements, or

wherein the at least one carrier comprises one position element and one reference marker.

36. The registration device according to claim 34,

wherein the at least one carrier comprises two reference markers.

37. The registration device according to claim 34, wherein the at least one carrier is mechanically connected, preferably releasably and preferably via clamping means, snap-fit means, and/or a fitting to the registration device, in particular to the at least one fixation means, body, and/or connection element.

38. The registration device according to claim 34, comprising two carriers each of which comprises at least one, preferably two, position elements, and at least one, preferably two, reference markers.

39. The registration device according to claim 1, wherein the registration device, particularly the fixation and/or clamping means, comprises at least a part or portion, which is adapted to interact with the surrounding internal body structure, so that the positioning of the registration device in, against, and/or through the soft tissue area of the patient'"'"'s body cavity causes a displacement of the internal body structure, such as the soft tissue, and/or the registration device, particularly of the fixation or clamping means, resulting in a fixed positioning, preferably clamping, of the registration device in the body cavity.

40. The registration device according to claim 39, wherein the part or portion is substantially rigid and the surrounding internal body structure is at least partially displaced and clamps the registration device.

41. The registration device according to claim 1, wherein the registration device, particularly the fixation and/or clamping means, comprises at least a part or portion, which substantially corresponds to the shape of an internal structure of the patient'"'"'s body cavity, and wherein the part or portion is adapted to position the registration device by interlocking, preferably by a form-fit.

42. The registration device according to claim 41, wherein the part or portion is adapted to be formed by the help of an imprint which substantially represents the shape of an internal structure inside a patient'"'"'s body cavity.

43. The registration device according to claim 1, wherein a part or portion is provided with an elasticity and/or resilience allowing the positioning of the registration device on or in, respectively, the internal structure inside a patient'"'"'s body cavity and the fixed positioning thereof by interlocking, preferably by a form fit and/or clamp or press fit.

44. The registration device according to claim 1, wherein the registration device comprises a structure, such as an indentation, a recess, and/or a centering part or centering portion which is/are preferably adapted to mate with, e.g., to receive and/or to center a clinical tool and/or a surgical probe.

45. The registration device according to claim 44, wherein the registration device is adapted to serve as a calibration point for calibration of a clinical tool or a surgical probe.

46. The registration device according to claim 1, wherein the registration device is not a mouth piece.

47. The registration device according to claim 1, wherein the registration device is not or does not comprise a bone marker and is not adapted to function as such.

48. The registration device according to claim 1, wherein the registration device is minimally invasive or least invasive, preferably non-invasive.

49. The registration device according to claim 1, wherein the registration device, preferably the respective mountings, comprises one, preferably two, position element, and/or

wherein registration device comprises at least two, preferably three reference markers.

50. The registration device according to claim 1, wherein mechanical connections between one or more of the different parts of the registration device, such as the body and the extension members, the carrier and the fixation means, the mountings and the position elements and/or reference markers are individually coded, preferably mechanically, to assure and necessitate predefined combination and/or orientation of elements.

51. The registration device according to claim 1, wherein the registration device is adapted to be manipulated to take a preferred, and preferably defined, position within the patient'"'"'s body cavity, and/or

wherein the position element and/or reference marker is/are located relative to one another and/or relative to the patient so that the registration error in the operation field is minimized;

preferably, the position of the reference marker and/or position element is adaptable within the patient'"'"'s body cavity to allow improved surgical navigation.

52. The registration device according to claim 1, wherein the registration device is adapted, preferably in its first physical extent, to be received in a delivery or application device.

53. The registration device according to claim 1, and an application device,

wherein the registration device is positionable in a patient'"'"'s body cavity by the application device,

wherein the application device comprises a holding element (to hold the registration device during the insertion in a patient'"'"'s body cavity, and

wherein the application device comprises an elongate portion and a handling member located at one end of the elongate portion opposite to the position of the holding element.

54. The registration device and application device according to claim 53, wherein the registration device is adapted to be handled, actuated and/or released from the holding element by the handling member.

55. The registration device and application device according to claim 53, wherein the holding element holds the registration device in a first physical extent and/or

wherein the holding element releases the registration device, allowing it to take a second physical extent resulting in or allowing positioning of the registration device in the patient'"'"'s body cavity by means of the fixation means upon operation of the handling member.

56. The registration device and application device according to claim 53, wherein the holding element is adapted to manipulate the registration device to take a second physical extent and/or to be positioned in a body cavity.

57. The registration device and application device according to claim 53, wherein the holding element comprises a cover, a sheath, a tube, a coil and/or clamping members.

58. The registration device and application device according to claim 53, wherein the holding element and/or the registration device is moveable relative to the application device and/or relative to the registration device or the holding element, particularly so as to release the registration device allowing it to take or approach its second physical extent.

59. The registration device according to claim 1, wherein the registration device comprises at least a portion or a part comprising a material which is adapted to be visualized by an imaging system,

wherein the portion or part preferably comprises a material with a high x-ray radiation absorption coefficient, a material adapted to be sensed by ultrasonographic imaging, CT, MR, PET, SPET or other suitable 2D- or 3D-imaging systems,

wherein the portion comprising a material which can be recognized by an imaging system is preferably adapted to be used for patient registration and more preferably constitutes a reference marker.

60. The registration device according to claim 1, wherein the registration device comprises at least a part or portion comprising a radiolucent material.

61. The registration device according to claim 1, wherein the registration device comprises or is made of biocompatible materials and/or materials adapted to be sterilized and re-used.

62. The registration device according to claim 1, wherein the registration device, the at least one reference marker, and/or the at least one position element is/are disposable.

63. The registration device according to claim 1, wherein the registration device comprises at least two elements of reference marker and/or position element, each of the at least two elements being provided with a unique shape and/or size.

64. The registration device according to claim 1, wherein the at least one reference marker is adapted to allow multimodal use with different types of imaging systems adapted for pre-operative and/or intra-operative use.

65. The registration device according to claim 1, wherein the at least one reference marker comprises and/or is made of ceramics, plastics, titanium, contrasting structures and/or has the shape of a small container.

66. The registration device according to claim 1, wherein the at least one marker is adapted to be filled with or comprises one or more contrast agents or contrasting materials.

67. The registration device according to claim 1, wherein the at least one position element is configured to be in communication with a position sensing system, and

wherein the at least one position element is configured in a way that its position is locatable by the position sensing system.

68. The registration device according to claim 1, wherein the at least one position element is a sensor and/or transponder.

69. The registration device according to claim 1, comprising at least one position element being a 6D-sensor, or comprising at least two position elements being 5D-sensors.

70. The registration device according to claim 1, wherein the at least one reference marker and the at least one position element are located at defined positions relative to one another, and/or

wherein the at least one reference marker mounting and the at least one position element mounting are located at defined positions relative to one another.

71. The registration device according to claim 1, wherein the registration device comprises at least two reference markers and at least one, preferably at least two, and also preferred three or more position element with defined and known relative positions.

72. The registration device according to claim 1, wherein at east one, preferably all, position element is/are adapted to serve as reference marker.

73. The registration device according to claim 1, wherein the at least one reference marker is releasably attachable to the registration device, preferably to the at least one reference marker mounting, and/or

wherein the at least one position element is releasably attachable to the registration device, preferably to the at least one position element mounting.

74. The registration device according to claim 6, wherein the at least one reference marker and/or the at least one position element is/are integrally formed, particularly in a single-pieced manner, with at least a portion, particularly with at least one extension member, of the registration device.

75. The registration device according to claim 30, wherein the at least one reference marker mounting and/or the at least one position element mounting comprises a clamping means, a snap-fit locking means, a caulking means, a self-locking clamp means, and/or a pressure fit connection means.

76. A kit comprising a registration device according to claim 1 and an application device.

77. A kit comprising a registration device according to claim 1, an application device and/or a probe,

wherein the probe preferably comprises at east one position element adapted to be localized by a position sensing system, and

wherein the probe is adapted to be guided along and to detect the shape of an anatomic marker of the patient, preferably of at least a part of the nasal septum.

80. The kit according to claim 77, wherein the at least one position element is located at the proximal end of the probe, and/or

wherein the probe comprises a curved end portion and/or female shaped end portion,

wherein the at least one position element is located at the curved end portion, and

wherein the at least one position element is preferably located on the apex of the curved end portion.

81. The kit according to claim 76,

wherein the kit further comprises at least one additional extrinsic marker, which is not part of the registration device.

82. A registration system, comprising a registration device according to claim 1 and a position sensing system and/or an imaging system.

83. The registration system according to claim 82, wherein the registration system comprises at least one additional intrinsic marker and/or extrinsic marker, which is not part of and/or separate from the registration device, and

wherein the at least one additional marker is preferably an anatomic marker of the patient and/or another extrinsic marker.

84. The registration system according to claim 82, wherein the registration system comprises a probe.

85. A method for patient registration, comprising the steps of:

providing a registration device according to claim 1,

positioning the registration device inside a patient'"'"'s body cavity at a location comprising soft tissue,

particularly in the viscerocranium such as the nasal cavity, the nasopharynx, the ear canal(s) and/or the neurocranium such as the cerebral ventricle,

sensing and visualizing at least one reference marker by an imaging system,

locating the position of at least one position element inside the patient by a position sensing system,

processing the data of the imaging system and the position sensing system in a processing means which preferably is in communication with the imaging system and/or the position sensing system, and

determining the position of the at least one position element and, if used, the at least one reference marker in the imagery provided by the imaging system

displaying the processed data, preferably in a user interface.

86. The method according to claim 85, wherein positioning the registration device comprises the steps of:

positioning the registration device on a holding element of an application device,

inserting the registration device into a body cavity using the application device,

releasing the registration device from the application device.

87. The method according to claim 85, wherein positioning of the registration device comprises the step of transition of the registration device from a first physical extent facilitating insertion of the registration device into a patient'"'"'s body cavity to a second physical extent allowing positioning of the registration device in the patient'"'"'s body cavity by means of the fixation means;

wherein the transition preferably does not include further steps apart from releasing the registration device from a holding element holding the device in a first physical extent, or

wherein the transition comprises the step of manipulating the device to take a second physical extent.

88. The method according to claim 85, wherein the positioning comprises a fixedly positioning by fixation means, preferably by clamping the registration device in the patient'"'"'s body cavity, preferably against or between walls of a patient'"'"'s body cavity, and/or by clamping the registration device on an internal structure inside a patient'"'"'s body cavity, preferably on the nasal septum.

89. The method according to claim 85, wherein the positioning of the registration device comprises a step of at least partly expanding, compressing and/or inflating at least a part of the registration device, particularly to achieve the second or first physical extent.

90. The method according to claim 85, wherein the positioning of the registration device comprises a step of moving at least one adjustment element relative to at least one extension member, the at least one adjustment element being adapted to urge the registration device at least partially from the first physical extent into the second physical extent, preferably by sliding the adjustment element along the extension member.

91. The method according to claim 90, wherein the registration device comprises at least two extension members with divergently extending first extension portions and preferably with engagement portions,

wherein the positioning of the registration device comprises a step of moving at least one adjustment element relative to, toward or onto the first extension portions, preferably toward the engagement portions,

so that at least some of the divergently extending first extension portions move at least partially in a converging manner.

92. The method according to claim 90, wherein the registration device comprises least two extension members with first and second extension portions and preferably engagement portions,

wherein the positioning of the registration device comprises a step of moving at least one adjustment element relative to the second extension portions, preferably toward the first extension portions, most preferably toward the engagement portions,

so that at least some of the second extension portions move at partially in a divergent manner.

93. The method according to claim 90, wherein the positioning of the registration device comprises a step of locking the at least one adjustment element with a locking means, preferably being configured as a latch, being adapted to reduce or avoid a movement of adjustment element relative to the at least one extension member.

94. The method according to claim 90, wherein the adjustment element is positioned at predefined positions.

95. The method according to claim 85, wherein the positioning of the registration device comprises a step of attaching the at least one carrier to the at least one fixation means before and/or after introduction into a patient'"'"'s body cavity.

96. The method, according to claim 85, wherein the position sensing system localizes the shape and position of an anatomic structure of the patient, preferably of at least a part of the nasal septum, wherein such shape is detected and sensed by means of at least One position element in communication with a position sensing system and provided on a probe, and wherein the probe is manually guided along the anatomic structure.

97. The method according to claim 85, wherein at least one additional intrinsic and/or extrinsic marker is used, which is separate from and/or not part of the registration device, and wherein the at least one additional marker is preferably an anatomic marker of the patient and/or another extrinsic marker.

98. The method according to claim 85, wherein the registration device comprises at least two position elements and at least one reference marker, wherein the spatial positions of the at least two position elements are sensed and provided to a computing means, and wherein the computing means processes the spatial positions to determine at least one position vector indicating the relative position of the at least two position elements.

99. The method according to claim 98, wherein the orientation and/or length and/or magnitude of the at least one position vector is, preferably continuously and in real-time or intermittently, monitored and/or displayed.

100. The method according to claim 98, wherein changes in the orientation and/or length and/or magnitude of the at least one position vector, preferably changes exceeding a predefined threshold value, trigger an alarm, preferably perceptible by the user, and/or make the computing means change the further processing to another position element the position of which has not changed.

101. The method according to claim 85, wherein the registration device comprises at least two position elements, wherein the position sensing system and/or the computing means are configured so that in the event of a failure of one position element another position element automatically takes over the function of the failed position element and/or is used for further processing, particularly for medical navigation.

102. A method of medical navigation, comprising the steps of the method according to claim 85, wherein the position sensing system is part of or constitutes or communicates with a navigation system, wherein surgical navigation is based on the results of patient registration, and wherein the position of a surgical instrument relative to the registration device is detected.

103. A method of medical navigation, comprising the steps of the method according to claim 85, wherein a clinical application accuracy near a surgical target is assessed by:

touching at least one reference marker of the registration device applied in the patient with a navigated probe forming a reference point, wherein the at least one reference marker has known image and spatial coordinates and was not used for the registration, and

measuring the clinical application accuracy of the reference point directly as the vectorial difference between spatial coordinates of said at least one reference point transformed into image coordinates and the at least one reference markers'"'"' corresponding image coordinates.

104. A method of medical navigation, comprising the steps of the method according to claim 85, wherein a clinical application accuracy near a surgical target is assessed by:

extracting the image position of at least one position element of the registration device which is adapted to serve as a reference marker and which was not used for the registration transforming them into its spatial coordinates with known registration transformation, yielding an error vector between the sensed position and the calculated position of the at least one position element.

78. A probe for patient registration, wherein the probe comprises at least one position element adapted to be localized by a position sensing system, and

wherein the probe is adapted to be guided along and to detect the shape and/or position of an anatomic marker of the patient, preferably of at least a part of the nasal septum.

79. The probe for patient registration according to claim 78, wherein the probe comprises a part or portion with a mating or negative shape which corresponds to the shape of an anatomic marker of the patient.