Hybrid imaging method to monitor medical device delivery and patient support for use in the method

• US 20050080333A1
• Filed: 08/12/2004
• Published: 04/14/2005
• Est. Priority Date: 09/30/2003
• Status: Active Grant

• Current Assignee: Invivo Corporation (Koninklijke Philips N.V.)
• Original Assignee: Sunnybrook Health Sciences Centre
• Inventors: Piron, Cameron Anthony, Luginbuhl, Christopher Alexander, Plewes, Donald B.
• Granted Patent: US 7,379,769 B2
• Time in Patent Office: Days
• US Class Current: 600/417
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• 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 2090/374 NMR or MRI
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 5/708 Breast positioning means
• CPC Class Codes: A61B 8/0825 for diagnosis of the breast, e.g. mammography
• 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 8/406 using means for diagnosing suspended breasts
• CPC Class Codes: A61B 8/4245 involving determining the position of the probe, e.g. with respect to an external reference frame or to the patient
• CPC Class Codes: A61B 8/4416 related to combined acquisition of different diagnostic modalities, e.g. combination of ultrasound and X-ray acquisitions
• CPC Class Codes: A61B 8/5238 for combining image data of patient, e.g. merging several images from different acquisition modes into one image for image registration algorithms G06T7/30
• CPC Class Codes: A61B 90/10 for stereotaxic surgery, e.g. frame-based stereotaxis
• CPC Class Codes: A61B 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: A61B 90/14 Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins
• CPC Class Codes: A61B 90/17 for soft tissue, e.g. breast-holding devices
• CPC Class Codes: G01S 7/52049 using correction of medium-induced phase aberration

Abstract

This invention discloses a method and apparatus to deliver medical devices to targeted locations within human tissues using imaging data. The method enables the target location to be obtained from one imaging system, followed by the use of a second imaging system to verify the final position of the device. In particular, the invention discloses a method based on the initial identification of tissue targets using MR imaging, followed by the use of ultrasound imaging to verify and monitor accurate needle positioning. The invention can be used for acquiring biopsy samples to determine the grade and stage of cancer in various tissues including the brain, breast, abdomen, spine, liver, and kidney. The method is also useful for delivery of markers to a specific site to facilitate surgical removal of diseased tissue, or for the targeted delivery of applicators that destroy diseased tissues in-situ.

Claims

1-62. -62. (canceled)

63. A method performed on an apparatus to monitor and optimize the placement of interventional medical devices in human tissues of a patient comprising

(a) imaging and positioning said interventional medical devices within said tissues on the basis of 3D MR imaging data;

(b) co-registering MR images and ultrasound images based on measurements of fiducial markers obtained during said MR imaging procedure;

(c) positioning the patient on the apparatus and enabling unrestricted access to points on the surface and within the volume of said tissues;

(d) the apparatus comprising a patient support structure, with associated patient transport stretcher that enables imaging and positioning of said interventional devices within said tissues.

64. The method of claim 63, wherein said tissues are positioned in a prescribed configuration with known reference points within said tissues, this positioning allowing MRI to be used outside the MR imager.

65. The method of claim 64, wherein said reference points within said tissue minimize MR imaging time and facilitate the guidance of MR-incompatible devices with MR data outside the imager.

66. The method of claim 63, wherein ultrasound transducers are guided to prescribed imaging planes to simplify co-registration of said imaging data, thereby permitting accurate guidance of multiple said interventional devices to multiple targets within said tissues through a single surgical incision.

67. An apparatus used to assist in monitoring and optimizing the placement of interventional medical devices in human breast tissues comprising

a patient support structure with an associated patient transport stretcher, the structure and the stretcher enabling imaging and positioning of the interventional devices within human breast tissues by providing breast support without restricting interventional access to the breast tissues,

the apparatus enabling access to points on the surface and within the volume of said breast.

68. The apparatus of claim 67 wherein breast compressing plates enabling bilateral imaging with both breasts are provided on the apparatus.

69. The apparatus of claim 67 wherein said apparatus allows access to areas near the chest wall from both lateral and medial approaches with only minimally interfering support structures.

70. The apparatus of claim 67, wherein said patient transport stretcher additionally provides

(a) a removable bridge providing a large volume in which to position said devices and gain access to the breast,

(b) a means of replacing said bridge such that continuous patient support is provided when said patient is moved in and out of the bore of the imager;

(c) lighting devices positioned to provide illumination from both medial and lateral access directions,

(d) mirrors positioned such that an operator may easily see the nipple of the breast when positioning the patient and applying compression to the breast;

(e) fluid collection device positioned under the breast undergoing imaging which covers medial and lateral aspects of said breast and moves with the patient into and out of the imager.

71. The apparatus of claim 67 wherein compression plates comprising multiple locking supports running along linear guides can be moved in medial/lateral directions, locked independently in any position, and introduced and removed from the apparatus with the patient lying on the support structure.

72. The apparatus of claim 71 wherein modular plate locking supports fix said compression plates for MR imaging.

73. The apparatus of claim 72 wherein said modular plate locking supports and said compression plates arte provided with single or multiple coils for MR imaging

74. The apparatus of claim 72 wherein said modular plate locking supports and said compression plates are provided with a fenestrated plate for MR interventions, Ultrasound imaging, and Ultrasound interventions.

75. The apparatus of claim 68 wherein said compression plates may be moved vertically, anterior-posterior to the patient, and locked relative to the compression frames to compress the breast near the chest wall.

76. The apparatus of claim 75 wherein said compression plates additionally provide fiducial markers as intra-modality reference points,

77. The apparatus of claim 75 wherein said compression plates also provide attachment points for imaging coils, device delivery devices, fiducial marker plate arrangements, and fenestrated immobilization plates.

78. The apparatus of claim 72 wherein said compression plates compress and immobilize the breast and incorporate an MR imaging coil or coil array in close contact with the breast.

79. The apparatus of claim 78 wherein said compression plates incorporate fiducial markers and an array of apertures providing access to the breast for interventions.

80. The apparatus of claim 79 wherein fenestrations in said compression plates are keyed to accept device guide plugs in only one orientation.

81. The apparatus of claim 80 wherein said fenestrations are packed in a hexagonal orientation.

82. The apparatus of claim 79 wherein said compression plate may be moved in the anterior/posterior direction relative to the patient.

83. The apparatus of claim 79 wherein said compression plate may be moved in a superior/inferior direction relative to the patient.

84. The apparatus of claim 79 wherein said compression plates consist of a frame supporting a membrane, allowing position adjustment of an attached fenestrated plate without disturbing the position of the breast.

85. The apparatus of claim 84 wherein the opening of said frame in said compression plates is large enough to provide access to the entire breast volume.

86. The apparatus of claim 84 wherein said membrane is sterile and can be replaced for each procedure.

87. The apparatus of claim 84 wherein said fenestrated frame can be locked into position relative to compression plate in various orientations, such that each orientation permits interventional access to a different volume of the breast.

88. The apparatus of claim 84 wherein said fenestrated plate has fenestrations positioned such that shifting said frame by the fenestration separation distance ensures improved access to breast volume.

89. The apparatus of claim 79 wherein said frame provides a set of attachment points for an ultrasound positioning system, fiducial markers and an adjustable fenestrated plate.

90. The apparatus of claim 79 wherein said frame supports a membrane permeable to ultrasound.

91. The apparatus of claim 90 wherein said membrane has an acoustic impedance matched to tissue being imaged.

92. The apparatus of claim 88 wherein said fenestrated plate is designed to allow an ultrasound transducer to come into contact with an ultrasound-permeable membrane.

93. The apparatus of claim 92 wherein said fenestrated plate contains apertures in which is inserted a set of device delivery guide plugs.

94. The apparatus of claim 80 wherein straight needle guide plugs are positioned into said keyed fenestrations of said interventional compression plates.

95. The apparatus of claim 80 wherein the needle guide plugs are positioned in said fenestrations of said interventional compression plates.

96. The apparatus of claim 94 wherein said guide plugs accommodate various needle gauges and can be adjusted through an angular range.

97. The apparatus of claim 94 wherein gimbaled guide plugs are constructed to allow angulation of the needle during insertion into the mounting frame or plate in only one orientation to preserve correct needle orientation relative to anatomy.

98. The apparatus of claim 97 wherein a goniometer accepts said gimbaled guide plug and positions the gimbal to the correct angular orientation for needle placement.

99. The apparatus of claim 98 wherein said goniometer has a detachable guide plug disc which can be removed for sterilization.

100. The apparatus of claim 98 wherein said goniometer also has a detachable needle guide extender which fits outside the needle guide and can be detached for sterilization.

115. An apparatus used to assist in monitoring and optimizing the placement of interventional medical devices in human breast tissues comprising

a patient support structure carried on an associated patient transport stretcher,

the patient support structure comprising a) a forward support surface that ramps upward towards at least one opening for positioning of breasts and then provides a more forward head support, b) an lower trunk support surface, and c) a structural element connecting a) and b), with an open area beneath the structural connection.

116. The apparatus of claim 115 wherein the at least one opening provides compression plates for the breasts that allow insertion of interventional devices into breast tissue while breasts are compressed.

117. The apparatus of claim 115 wherein at least part of the structural element is retractable.

118. The apparatus of claim 116 wherein at least part of the structural element is retractable.

119. The apparatus of claim 116 wherein the patient support structure rolls on guides connected to the stretcher to allow extension of the patient support structure into a bore of an MR imager.

120. The apparatus of claim 116 wherein a removable section exists between a) and b) and that removable section may be removed without eliminating structural connection between a) and b).

121. The apparatus of claim 116 wherein fenestrations are provided in the compression plates to enable insertion of interventional medical devices into the breast tissue.

122. The apparatus of claim 121 wherein a gimballing support for interventional medical devices is present in at least one fenestration in at least one compression plate.