Patent Grant
8644906
The present invention relates generally to medical systems and methods and, more particularly, to in vivo medical systems and methods.
Deep Brain Stimulation (DBS) is becoming an acceptable therapeutic modality in neurosurgical treatment of patients suffering from chronic pain, Parkinson's disease or seizure, and other medical conditions. Other electro-stimulation therapies have also been carried out or proposed using internal stimulation of the sympathetic nerve chain and/or spinal cord, etc.
One example of a prior art DBS system is the Activa® system from Medtronic, Inc. The Activa® system includes an implantable pulse generator stimulator that is positioned in the chest cavity of the patient and a lead with axially spaced apart electrodes that is implanted with the electrodes disposed in neural tissue. The lead is tunneled subsurface from the brain to the chest cavity connecting the electrodes with the pulse generator. These leads can have multiple exposed electrodes at the distal end that are connected to conductors which run along the length of the lead and connect to the pulse generator placed in the chest cavity.
It is believed that the clinical outcome of certain medical procedures, particularly those using DBS, may depend on the precise location of the electrodes that are in contact with the tissue of interest. For example, to treat Parkinson's tremor, presently the DBS probes are placed in neural tissue with the electrodes transmitting a signal to the thalamus region of the brain. DBS stimulation leads are conventionally implanted during a stereotactic surgery, based on pre-operative MRI and CT images. These procedures can be long in duration and may have reduced efficacy as it has been reported that, in about 30% of the patients implanted with these devices, the clinical efficacy of the device/procedure is less than optimum. Notwithstanding the above, there remains a need for alternative MRI-guided interventional tools for DBS, as well as for other interventional medical procedures.
According to embodiments of the present invention, an MRI-compatible patch for identifying a location includes a flexible base layer, a flexible substrate and at least one MRI-visible fiducial element. The flexible base layer is mountable on and substantially conformable to a patient's body surface. The base layer has opposed upper and lower primary surfaces. The flexible substrate is releasably attached to the upper primary surface of the base layer and substantially conformable to the patient's body surface. The at least one MRI-visible fiducial element is defined by or secured to the flexible substrate. The MRI-visible fiducial elements are arranged in a defined pattern.
According to some embodiments, the patch includes an adhesive to releasably attach the flexible substrate to the base layer.
The patch may include an adhesive disposed on the lower primary surface of the base layer to attach the base layer to the body surface.
The patch may include indicia on the base layer corresponding to the MRI-visible fiducial elements on the flexible substrate. The patch may include second indicia on the flexible substrate corresponding to the indicia on the base layer.
In some embodiments, the patch includes a plurality of the MRI-visible fiducial elements. The fiducial elements may be arranged in a defined pattern. Indicia may be provided on the base layer corresponding to the MRI-visible fiducial elements on the flexible substrate, wherein the indicia has a second prescribed pattern having a higher resolution than the defined pattern of the MRI-visible fiducial elements on the flexible substrate. In some embodiments, the defined pattern includes a grid pattern defining a coordinate system. The patch may include codified indicia representing the coordinate system.
The flexible substrate can include a pull tab to facilitate removal of the flexible substrate from the base layer.
In some embodiments, the base layer is frangible to permit selective access to the body surface when the base layer is mounted thereon and the flexible substrate has been at least partially removed.
According to some embodiments, the patch includes at least one MRI-visible reference indicator to indicate an orientation of the patch.
In some embodiments, at least one of the MRI-visible fiducial elements has a first MRI-visible geometric shape, and at least one of the MRI-visible fiducial elements has a second MRI-visible geometric shape different from the first MRI-visible geometric shape.
According to some embodiments, at least some of the MRI-visible fiducial elements include a pocket containing MRI-visible material. The MRI-visible material may include an MRI-visible liquid.
At least some of the MRI-visible fiducial elements may be selectively discretely removable from the flexible substrate to permit access to the body surface.
According to some embodiments, the patch includes perforations defined in the flexible substrate to thereby enhance conformity of the flexible substrate to the body surface.
The flexible substrate can be formed of a stretchable material to allow the flexible substrate to conform to a head body surface.
According to some embodiments, the flexible substrate has a thickness in the range of from about 0.001 to 0.100 inches.
According to some embodiments, the flexible substrate is a substrate material selected from the group consisting of polyvinyl, PET, silicone, polyethylene, polyurethane, and polyamide.
According to some embodiments, the patch further includes: a plurality of MRI-visible fiducial elements defined by or secured to the flexible substrate, wherein the fiducial elements are arranged in a defined pattern; an adhesive disposed on the lower primary surface of the base layer to attach the base layer to the body surface; a release liner backing and releasably secured to the adhesive; and indicia on the base layer corresponding to the MRI-visible fiducial elements on the flexible substrate; and at least one MRI-visible reference indicator to indicate an orientation of the patch; wherein at least some of the MRI-visible fiducial elements include a pocket containing MRI-visible liquid, and wherein the defined pattern includes a grid pattern defining a coordinate system.
According to embodiments of the present invention, a method for identifying a physical location on a body surface of a patient includes providing a patch including: a flexible base layer that is mountable on and substantially conformable to a patient's body surface, the base layer having opposed upper and lower primary surfaces; a flexible substrate that is releasably attached to the upper primary surface of the base layer and substantially conformable to the patient's body surface; and at least one MRI-visible fiducial element defined by or secured to the flexible substrate. The method further includes: securing the base layer to the body surface to mount the patch on the body surface such that the flexible substrate conforms to the body surface; MRI scanning the patient with the patch on the body surface to generate corresponding image data; identifying a physical location on the body surface using the image data; and removing the flexible substrate from the base layer.
According to some embodiments, the patch includes a plurality of the MRI-visible fiducial elements. In some embodiments, the fiducial elements are arranged in a defined pattern.
According to embodiments of the present invention, a method for identifying a physical location on a body surface of a patient residing in physical space includes providing a patch residing in physical space and including: a flexible substrate that is mountable on and substantially conformable to the body surface; and at least one MRI-visible fiducial element defined by or secured to the flexible substrate. The method further includes: mounting the patch on the body surface such that the flexible substrate conforms to the body surface; MRI scanning the patient with the patch on the body surface to generate corresponding image data; and identifying a physical location on the body surface using the image data, including: generating an image of the patient in a logical space; determining in the logical space a desired entry location on the body surface for insertion of instrumentation into the patient; and programmatically determining a physical location on the patch corresponding to the desired entry location.
In some embodiments, determining in the logical space the desired entry location includes determining a desired trajectory line, and determining the physical location on the patch corresponding to the desired entry location includes determining a location of intersection between the desired trajectory line and the patch. The method may include programmatically determining in the logical space the desired entry location and the desired trajectory line. The method can include displaying the desired entry location and the desired trajectory line on a display device to an operator.
According to some embodiments, the patch includes a plurality of the MRI-visible fiducial elements. In some embodiments, the fiducial elements are arranged in a defined pattern. According to some embodiments, the method includes displaying the image of the patient and a graphical overlay on a display to an operator. The graphical overlay indicates at least a portion of the defined pattern of the MRI-visible fiducial elements.
The method may further include marking the body surface at a location corresponding to the physical location on the patch.
According to some embodiments, the body surface is on the patient's head and the method includes forming a burr hole in the patient's skull proximate the physical location.
The mounting step may comprise releasably attaching the flexible substrate to the body surface prior to the step of MRI scanning the patient with the patch on the body surface. According to some embodiments, the patch includes a flexible base layer having opposed upper and lower primary surfaces, wherein the flexible substrate is releasably attached to the upper primary surface of the base layer, and the method includes: securing the base layer to the body surface prior to the step of MRI scanning the patient with the patch on the body surface; and removing the flexible substrate from the base layer after the step of MRI scanning the patient with the patch on the body surface.
The method may include removing at least one of the fiducial elements from the flexible substrate after the step of MRI scanning the patient with the patch on the body surface to permit access to the body surface.
In some embodiments, at least some of the MRI-visible fiducial elements include a pocket containing MRI-visible material.
In some embodiments, the method includes: mounting a plurality of the patches on the body surface in close proximity to one another; and thereafter MRI scanning the patient with the plurality of patches on the body surface to generate corresponding image data.
According to some embodiments, MRI scanning the patient with the patch on the body surface includes MRI scanning an MRI-visible reference indicator on the patch to generate corresponding reference image data. The method further includes programmatically determining an orientation of the patch using the reference image data.
According to embodiments of the present invention, a computer program product for identifying a physical location on a body surface of a patient using a patch mounted on the body surface and including at least one MRI-visible fiducial element includes a computer readable medium having computer usable program code embodied therein, the computer readable program code comprising: computer readable program code configured to generate an image of the patient and the patch in a logical space, the image corresponding to an MRI scan of the patient with the patch on the body surface; computer readable program code configured to determine in the logical space a desired trajectory line for insertion of instrumentation into the patient; and computer usable program code configured to programmatically determine a location of intersection between the desired trajectory line and the patch.
According to embodiments of the present invention, a system for designating a physical location on a body surface of a patient includes a patch and a controller. The patch includes: a flexible substrate that is mountable on and conformable to the body surface; and at least one MRI-visible fiducial element defined by or secured to the flexible substrate. The controller is adapted to communicate with an MRI scanner that is operable to scan the patient with the patch on the body surface and to generate corresponding image data. The controller processes the image data from the MRI scanner to programmatically identify a physical location on the body surface.
In some embodiments, the controller is operable to display correlated representations of the at least fiducial element and the patient.
According to embodiments of the present invention, a medical (surgical) kit for designating a physical location on a head of a patient includes a patch and a head marking tool. The patch includes a flexible base layer, a flexible substrate and at least one MRI-visible fiducial element. The flexible base layer is mountable on and substantially conformable to a patient's body surface. The base layer has opposed upper and lower primary surfaces. The flexible substrate is releasably attached to the upper primary surface of the base layer and substantially conformable to the patient's body surface. The MRI-visible fiducial element is defined by or secured to the flexible substrate. The head marking tool is configured to mark the head of the patient.
In some embodiments, the head marking tool is configured to mark a skull of the patent.
According to embodiments of the present invention, an MRI-compatible patch for identifying a location includes a flexible substrate that is mountable on and substantially conformable to a patient's body surface. A plurality of MRI-visible fiducial elements are defined by or secured to the flexible substrate. The MRI-visible fiducial elements are arranged in a defined pattern. The plurality of MRI-visible fiducial elements include at least one MRI-visible reference indicator to indicate an orientation of the patch.
According to embodiments of the present invention, a method for identifying a physical location on a body surface of a patient residing in physical space includes providing a patch residing in physical space and including: a flexible substrate that is mountable on and substantially conformable to the body surface; and at least one MRI-visible fiducial element defined by or secured to the flexible substrate. The method further includes: mounting the patch on the body surface such that the flexible substrate conforms to the body surface; MRI scanning the patient with the patch on the body surface to generate corresponding image data; generating an image of the patient in a logical space; and programmatically determining an orientation of the patch in the logical space using the image data.
In some embodiments, the patch includes an MRI-visible reference indicator and programmatically determining the orientation of the patch in the logical space using the image data includes programmatically determining the orientation of the patch in the logical space using image data corresponding to the MRI-visible reference indicator.
Further features, advantages and details of the present invention will be appreciated by those of ordinary skill in the art from a reading of the figures and the detailed description of the preferred embodiments that follow, such description being merely illustrative of the present invention.
The present invention now is described more fully hereinafter with reference to the accompanying drawings, in which some embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.
Like numbers refer to like elements throughout. In the figures, the thickness of certain lines, layers, components, elements or features may be exaggerated for clarity.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items.
Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the specification and relevant art and should not be interpreted in an idealized or overly formal sense unless expressly so defined herein. Well-known functions or constructions may not be described in detail for brevity and/or clarity.
It will be understood that when an element is referred to as being “on”, “attached” to, “connected” to, “coupled” with, “contacting”, etc., another element, it can be directly on, attached to, connected to, coupled with or contacting the other element or intervening elements may also be present. In contrast, when an element is referred to as being, for example, “directly on”, “directly attached” to, “directly connected” to, “directly coupled” with or “directly contacting” another element, there are no intervening elements present. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.
Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of “over” and “under”. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
Exemplary embodiments are described below with reference to block diagrams and/or flowchart illustrations of methods, apparatus (systems and/or devices) and/or computer program products. It is understood that a block of the block diagrams and/or flowchart illustrations, and combinations of blocks in the block diagrams and/or flowchart illustrations, can be implemented by computer program instructions. These computer program instructions may be provided to a processor of a general purpose computer, special purpose computer, and/or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer and/or other programmable data processing apparatus, create means (functionality) and/or structure for implementing the functions/acts specified in the block diagrams and/or flowchart block or blocks.
These computer program instructions may also be stored in a computer-readable memory that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory produce an article of manufacture including instructions which implement the functions/acts specified in the block diagrams and/or flowchart block or blocks.
The computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer or other programmable apparatus to produce a computer-implemented process such that the instructions which execute on the computer or other programmable apparatus provide steps for implementing the functions/acts specified in the block diagrams and/or flowchart block or blocks.
Accordingly, exemplary embodiments may be implemented in hardware and/or in software (including firmware, resident software, micro-code, etc.). Furthermore, exemplary embodiments may take the form of a computer program product on a computer-usable or computer-readable storage medium having computer-usable or computer-readable program code embodied in the medium for use by or in connection with an instruction execution system. In the context of this document, a computer-usable or computer-readable medium may be any medium that can contain, store, communicate, propagate, or transport the program for use by or in connection with the instruction execution system, apparatus, or device.
The computer-usable or computer-readable medium may be, for example but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, device, or propagation medium. More specific examples (a non-exhaustive list) of the computer-readable medium would include the following: an electrical connection having one or more wires, a portable computer diskette, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), an optical fiber, and a portable compact disc read-only memory (CD-ROM). Note that the computer-usable or computer-readable medium could even be paper or another suitable medium upon which the program is printed, as the program can be electronically captured, via, for instance, optical scanning of the paper or other medium, then compiled, interpreted, or otherwise processed in a suitable manner, if necessary, and then stored in a computer memory.
Computer program code for carrying out operations of data processing systems discussed herein may be written in a high-level programming language, such as Java, AJAX (Asynchronous JavaScript), C, and/or C++, for development convenience. In addition, computer program code for carrying out operations of exemplary embodiments may also be written in other programming languages, such as, but not limited to, interpreted languages. Some modules or routines may be written in assembly language or even micro-code to enhance performance and/or memory usage. However, embodiments are not limited to a particular programming language. It will be further appreciated that the functionality of any or all of the program modules may also be implemented using discrete hardware components, one or more application specific integrated circuits (ASICs), or a programmed digital signal processor or microcontroller.
The flowcharts and block diagrams of certain of the figures herein illustrate exemplary architecture, functionality, and operation of possible implementations of embodiments of the present invention. In this regard, each block in the flow charts or block diagrams represents a module, segment, or portion of code, which comprises one or more executable instructions for implementing the specified logical function(s). It should also be noted that in some alternative implementations, the functions noted in the blocks may occur out of the order noted in the figures. For example, two blocks shown in succession may in fact be executed substantially.
The term “MRI-visible” means that a device or feature thereof is visible, directly or indirectly, in an MRI image. The visibility may be indicated by the increased SNR of the MRI signal proximate to the device (the device can act as an MRI receive antenna to collect signal from local tissue) and/or that the device actually generates MRI signal itself, such as via suitable hydro-based coatings and/or fluid (typically aqueous solutions) filled cavities.
The term “MRI-compatible” means that a device is safe for use in an MRI environment and/or can operate as intended in an MRI environment, and, as such, if residing within the high-field strength region of the magnetic field, is typically made of a non-ferromagnetic MRI-compatible material(s) suitable to reside and/or operate in a high magnetic field environment.
The term “programmatically” refers to operations directed and/or primarily carried out electronically by computer program modules, code and instructions.
The term “fiducial marker” refers to a marker that can be identified visually and/or using electronic image recognition, electronic interrogation of MRI image data, or three-dimensional electrical signals to define a position and/or find the feature or component in 3-D space.
Patches in accordance with embodiments of the present invention can be configured to identify or designate a location on a body. The location may be identified in order to determine a desired position, orientation or operation of a guide apparatus. The guide apparatus may be used to guide and/or place diagnostic or interventional devices and/or therapies to any desired internal region of the body or object using MRI and/or in an MRI scanner or MRI interventional suite. The object can be any object, and may be particularly suitable for animal and/or human subjects. In some embodiments, the guide apparatus is used to place implantable DBS leads for brain stimulation, typically deep brain stimulation. In some embodiments, the guide apparatus can be configured to deliver tools or therapies that stimulate a desired region of the sympathetic nerve chain. Other uses inside or outside the brain include stem cell placement, gene therapy or drug delivery for treating physiological conditions. Some embodiments can be used to treat tumors. Some embodiments can be used for RF ablation, laser ablation, cryogenic ablation, etc. In some embodiments, the interventional tools can be configured to facilitate high resolution imaging via intrabody imaging coils (receive antennas), and/or the interventional tools can be configured to stimulate local tissue, which can facilitate confirmation of proper location by generating a physiologic feedback (observed physical reaction or via fMRI).
In some embodiments, the patch is used to identify a location on the body for delivering bions, stem cells or other target cells to site-specific regions in the body, such as neurological target and the like. In some embodiments, the patch is used to identify a location on the body for introducing stem cells and/or other cardio-rebuilding cells or products into cardiac tissue, such as a heart wall via a minimally invasive MRI-guided procedure, while the heart is beating (i.e., not requiring a non-beating heart with the patient on a heart-lung machine). Examples of known stimulation treatments and/or target body regions are described in U.S. Pat. Nos. 6,708,064; 6,438,423; 6,356,786; 6,526,318; 6,405,079; 6,167,311; 6539,263; 6,609,030 and 6,050,992, the contents of which are hereby incorporated by reference as if recited in full herein.
Generally stated, some embodiments of the invention are directed to MRI interventional procedures including locally placing interventional tools or therapies in vivo to site-specific regions using an MRI system. The interventional tools can be used to define an MRI-guided trajectory or access path to an in vivo treatment site.
In some embodiments, MRI can be used to visualize (and/or locate) a therapeutic region of interest inside the brain or other body locations, to visualize an MRI-visible patch according to embodiments of the present invention, and to visualize (and/or locate) an interventional tool or tools that will be used to deliver therapy and/or to place a chronically implanted device that will deliver one ore more therapies. Then, using the three-dimensional data produced by the MRI system regarding the location of the therapeutic region of interest and the location of the interventional tool, the system and/or physician can make positional adjustments to the interventional tool so as to align the trajectory of the interventional tool, so that when inserted into the body, the interventional tool will intersect with the therapeutic region of interest. With the interventional tool now aligned with the therapeutic region of interest, an interventional probe can be advanced, such as through an open lumen inside of the interventional tool, so that the interventional probe follows the trajectory of the interventional tool and proceeds to the therapeutic region of interest.
According to some methods of the present invention and with reference to
According to some embodiments of the present invention and with reference to
With reference to
With reference to
The base layer 110 is formed of a flexible material. According to some embodiments, the base layer 110 is formed of a biocompatible polymeric material suitable for surgical use in MRI systems. Suitable polymeric materials may include polyvinyl, PET, silicone, polyethylene, polyurethane, and/or polyamide.
According to some embodiments, the base layer 110 has a thickness in the range of from about 0.001 to 0.100 inches. According to some embodiments, the base layer 110 has a total area in the range of from about 1 to 900 cm2.
According to some embodiments, the base adhesive 120 is a biocompatible adhesive that has adhesive properties that ensure a secure, but releasable, bond with human skin and/or an incise drape.
With reference to
The outer layer 136 is attached to the inner layer 134 at seams 144 (
The layers 134, 136 are formed of a flexible material. According to some embodiments, the layers 134, 136 are formed of a polymeric material. Suitable polymeric materials may include polyvinyl, PET, silicone, polyethylene, polyurethane, and/or polyamide.
The MRI-visible material 146 may be any suitable material. According to some embodiments, the MRI-visible material 146 is a liquid. According to some embodiments, the MRI-visible material 146 includes sterile saline or water (e.g., deionized water), with or without vitamin E and/or Gadolidium.
According to some embodiments, each pocket 142 has a volume in the range of about 50 to 500 microliters. According to some embodiments, each pocket 142 has a nominal height in the range of from about 0.010 to 1 inch. According to some embodiments, each pocket 142 has an area in the range of from about 4 mm2 to 4 cm2.
According to some embodiments, the top layer 130 has a nominal thickness in the range of from about 0.001 to 0.1 inch. According to some embodiments, the top layer 130 has a total area in the range of from about 1 to 900 cm2.
According to some embodiments, the top adhesive 122 is a biocompatible adhesive that has adhesive properties that ensure a secure, but releasable bond with base layer 110.
The MRI-visible tabs 140 can be arranged in a defined pattern 163 (
According to some embodiments, the predefined tab array 168 includes a grouping of at least five-by-five tabs 140.
The reference tab 140R of the tab array 140 is positioned to indicate an orientation of the top layer 130. According to some embodiments, the reference tab 140R (or other reference MRI-visible fiducial element) has a shape that is discernably dissimilar from the other tabs 140 in an MR image. In this case, the reference tab 140R may not be positioned to indicate the orientation, but rather the orientation may be indicated by the orientation of the reference tab 140R.
Base indicia 150 (
Greater on lesser numbers of rows, columns, markers, and subsectors may be provide.
The indicia 154, 156 serve as codified indicia representing or corresponding to the coordinate system 161 of the tab array 168. Each of the sectors 152A may be sized and positioned to substantially coextensively align with a respective matched or overlying one of the tabs 140. The prescribed pattern of the base indicia 150 has higher resolution than the defined pattern of the array 168 of MRI-visible tabs 140 because the base indicia 150 further include the subsector marks 158 in each sector 152A.
Operations associated with an exemplary surgical procedure using the patch assembly 101, according to some embodiments of the present invention, will now be described with further reference to
With reference to
The controller 24 may be any suitable computer(s) or the like adapted to carry out the functions described herein. The user interface 26 may include a man-machine interface to enable an operator to access and control operations of the system 15. The controller 24 can be operably connected to each of the display 22 and the MRI scanner 20.
The surface of the patient's head 12 is suitably prepared by shaving and cleaning, for example. The release liner 102 is peeled away from the base layer 110 to expose the base adhesive 120 (
With the patch 100 adhered to the patient's head 12, the patient is placed within an MRI scanner 20. The MRI scanner scans the head 12 and generates corresponding MR image data. From the MR image data, MR images are obtained of the patient's head that visualize the patient's skull and brain. The MR images also visualize the MRI-visible masses 146 of the patch 100, which serve as MRI-visible landmarks. The MR images can include volumetric high-resolution images of the brain.
With reference to
A target point TP within the target region TR is selected and designated in a logical space in the MR image. A planned trajectory line PTL is selected and designated extending from the target point TP to a desired reference point (such as an operative pivot point of the trajectory guide apparatus 44 discussed hereinbelow). The planned trajectory line PTL extends through an entry surface of the head 12 at a desired entry location point EP in the logical space. According to some embodiments, the pivot point is located at or proximate the entry location point EP. Images are obtained in the planned plane of trajectory to confirm that the trajectory is viable (i.e., that no complications with anatomically sensitive areas should occur). The steps of identifying the target region TR, identifying the target point TP, and/or selecting and designating the planned trajectory line PTL may be executed using or with the aid of the trajectory guide module 24B, for example.
A point of intersection IP between the logical planned trajectory line PTL and the patch 100 in the logical space is determined. More particularly, according to some embodiments, the point of intersection IP between the planned trajectory line PTL and the array 168 of MRI-visible masses 146 is determined.
The intersection point IP may be determined by visually displaying the same on the display 22 where it can be readily identified by the operator (for example, as shown in
Alternatively or additionally, the controller 24 may programmatically identify or recognize and analyze and/or report the MRI-visible masses 146 in the image data.
According to some embodiments, the controller 24 (e.g., using the patch recognition module 24A) processes the acquired image data to programmatically recognize, orient and place the patch 100 in the logical space. According to some embodiments, the controller 24 uses an algorithm to programmatically determine the position of the tab array 168 in the logical space. According to some embodiments, the controller uses a pre-stored reference image or images to programmatically determine the position of the tab array 168 in the logical space.
Once the controller 24 has assessed the position (e.g., including orientation) of the patch 100 in the logical space, the controller 24 can use this data to identify the intersection point IP or enable or assist identification of the intersection point IP by the operator. For example, the controller 24 may enhance (e.g., add increased image contrast) or insert highlighted representations of the tabs 140 into the image 30 as provided on the display 22 in order to make the intersected tab 140 and/or the tab array 168 visually stand out in the image 30.
According to some embodiments, the controller 24 generates, fits and overlays or superimposes a graphical grid overlay 31 onto the MR image 30 as shown in
The controller 24 may determine and report or indicate the coordinates from the grid 163 corresponding to the intersection point IP to the operator (e.g., visually via the display 22 and/or audibly via a sound transducer). For example, in
The reference tab 140R can be identified in the image 30 and used by the operator and/or the controller 24 to determine and register the orientation of the coordinate system 161 of the patch 100 in the logical (i.e., MR volume) frame of reference.
The controller 24 can provide various additional functionality once it has recognized the tab array 168 in the MR image 30. According to some embodiments, the controller 24 will issue an alert (e.g., visible or audible) to the operator if the planned trajectory line PTL does not intersect the grid 163. According to some embodiments, the controller 24 will initially position a provisional planned trajectory line through the center of the grid 163. The operator can then move the provisional planned trajectory line in the display as needed to arrive at the desired ultimate planned trajectory line PTL.
The physical location on the top layer 130 corresponding to the intersection point IP can be readily determined using the image from the MR image data (e.g., by comparison to the image of the tabs 140 in the MR image and/or by reference to the coordinate system 161). Because the top layer 130 is affixed to the head 12 and the relationship between the patient's scalp and the MRI-visible tabs 140 is thereby maintained, the physical location of the intersection point IP (and, thus, the entry location point EP) can likewise be readily identified.
According to some embodiments and as illustrated, the thickness of the patch 100 between the tabs 140 and the underlying surface of the head 12 is thin (e.g., no more than 0.003 and 0.100 inch) so that the intersection point IP between the planned trajectory line PTL and the array 168 is substantially the same or closely proximate the intersection point between the planned trajectory line PTL and the surface of the head 12.
Once the MR image(s) have been acquired for determining the intersection point IP, the patient can be withdrawn from the scanning apparatus 20 to facilitate access to the patient's head 12. The operator removes the top layer 130 from the base layer 110 to reveal the base layer 110 by lifting an edge of the top layer 130 and peeling the top layer 130 away from the base layer 110 as shown in
With the base layer 110 remaining on the head 12 and exposed, the operator identifies the location (referred to herein as the label point LP) on the base layer 110 corresponding to the location of the intersection point IP in the top layer 130. This identification may be enabled by a prescribed correspondence between the coordinate system 151 of the base layer 110 and the array 168 of MRI-visible tabs 140 (
Having identified the label point LP, the operator may thereafter mark the head 12 at a location on the head surface corresponding to the label point LP. According to some embodiments, the operator marks the head surface at a location immediately below the label point LP. It will be appreciated that this location on the head surface is substantially the same as the intended entry location point EP designated above for the planned trajectory line PTL. The patch 100 thus can provide precise correlation between the logical points in the scanned MR volume and the physical patient.
The operator can mark the head 12 at or proximate the desired entry location using a suitable tool or implement. According to some embodiments and as shown in
The base layer 110 is removed (e.g., peeled away) from the head 12 as shown in
A burr hole 16 (
The procedure may thereafter be continued using the burr hole 16 as an access portal to the brain and employing suitable instrumentation such as the trajectory guide apparatus 44. The trajectory guide apparatus 44 can be fixed to the skull of the patient as shown in
In some embodiments, the controller 24 is in communication with a graphical user interface (GUI) that allows a clinician to define a desired trajectory and/or end position on a displayed image, then can electronically convert the orientation/site input data programmatically to generate position data for the trajectory guide apparatus 44. The GUI can include an interactive tool that allows a clinician to draw, trace or otherwise select and/or identify the target treatment site and/or access path trajectory. The system 15 can then be configured to identify adjustments to the trajectory guide apparatus 44 that are most likely to achieve this trajectory.
In some embodiments, the user interface 26 can be configured to electronically determine the location of a targeting cannula and a trajectory associated therewith. The user interface 26 can be configured to display MRI images with the planned trajectory and intersection point(s) that will be followed if the interventional/surgical device/lead is advanced using a defined position of the trajectory guide apparatus 44.
According to some embodiments the patch assembly 101 is packaged as a medical kit with the marking tool 40. The patch assembly 101 may be used in conjunction with a burr hole forming tool (e.g., a drill) configured to drill, cut or otherwise form a burr hole through the patient's skull 12. According to some embodiments, the marking tool 40 and the burr hole forming tool are formed of MRI-compatible materials.
With reference to
With reference to
With reference to
With reference to
With reference to
With reference to
With reference to
With reference to
The ink 1180 may be any suitable material that can transfer from the base layer 1110 to the patient's scalp, bond or adhere to the scalp, and provide a suitably visible contrast with the scalp. The ink may be a liquid or powder, for example.
According to further embodiments, the ink supply may be provided in or on the substrate including the MRI-visible tabs (e.g., the top layer 130) in which case the base layer (e.g., the base layer 110) can be omitted. The substrate can be removed after the MRI scan is taken, leaving the ink pattern on the scalp of the head 12 to provide the reference grid on the head 12 for locating the physical location of the intersection point IP.
With reference to
Still further embodiments of the present invention may incorporate aspects or features as described herein in other forms, combinations and/or applications. For example, a flexible substrate having selectively removable MRI-visible tabs (such as the substrate 730 and the tabs 740) may be provided without a base layer (e.g., the base layer 710) and may be directly applied to a patient's body surface or incise drape.
By way of further example, a patch may be provided having a base layer (e.g., corresponding to the base layer 110) and a removable top layer (e.g., corresponding to the top layer 130), but wherein the top layer carries only a single (i.e., exactly one) MRI-visible fiducial element or tab. The single MRI-visible fiducial element may have an asymmetric shape that is discernable in an MRI image so that the orientation of the patch in the logical space can be determined from the MRI image data. According to some method embodiments, the orientation of a patch (with or without a base layer) having only a single MRI-visible fiducial element is programmatically determined (e.g., by the controller 24) from the MRI image data. According to still further embodiments, the patch (with our without a base layer) may have a plurality of MRI-visible fiducial elements, but wherein the fiducial elements are not arranged in a defined pattern.
Two patches (or groups of patches) in accordance with the present invention (e.g., two of the patches 100) can be employed together to identify and mark two entry location points for a bilateral surgical procedure on a patient's head. The two patches 100 may be concurrently mounted on the head and each patch used in the same manner as discussed above. In this case, the controller 24 may programmatically distinguish between the two patches and their respective planned trajectory lines PTL so that the point of intersection IP for each patch can be determined independently of the other. The controller 24 may simultaneously display the patches 100 and their associated points of intersection IP, planned trajectory lines PTL, graphical overlays and the like.
The system 15 (
As shown in
As will be appreciated by those of skill in the art, the operating systems 452 may be any operating system suitable for use with a data processing system, such as OS/2, AIX, DOS, OS/390 or System390 from International Business Machines Corporation, Armonk, N.Y., Windows CE, Windows NT, Windows95, Windows98, Windows2000 or other Windows versions from Microsoft Corporation, Redmond, Wash., Unix or Linux or FreeBSD, Palm OS from Palm, Inc., Mac OS from Apple Computer, LabView, or proprietary operating systems. The I/O device drivers 92 typically include software routines accessed through the operating system 86 by the application programs 88 to communicate with devices such as I/O data port(s), data storage 90 and certain memory 84 components. The application programs 88 are illustrative of the programs that implement the various features of the data processing system and can include at least one application, which supports operations according to embodiments of the present invention. Finally, the data 90 represents the static and dynamic data used by the application programs 88, the operating system 86, the I/O device drivers 92, and other software programs that may reside in the memory 84.
While the present invention is illustrated, for example, with reference to the modules 24A-24B being application programs in
The I/O data port can be used to transfer information between the data processing system, the MRI scanner, the tool and another computer system or a network (e.g., the Internet) or to other devices controlled by the processor. These components may be conventional components such as those used in many conventional data processing systems, which may be configured in accordance with the present invention to operate as described herein.
The foregoing is illustrative of the present invention and is not to be construed as limiting thereof. Although a few exemplary embodiments of this invention have been described, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the claims. The invention is defined by the following claims, with equivalents of the claims to be included therein.
This application is a divisional of and claims priority from U.S. patent application Ser. No. 12/236,621, filed Sep. 24, 2008, now U.S. Pat. No. 8,195,272, which claims the benefit of and priority to U.S. Provisional Patent Application No. 60/974,821, filed Sep. 24, 2007, the disclosures of which are incorporated herein by reference as if set forth in their entireties.
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| 20120238864 A1 | Sep 2012 | US |
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| Parent | 12236621 | Sep 2008 | US |
| Child | 13460776 | US |
