This disclosure relates to medical instruments and more particularly to a system and method to track a needle under ultrasound guidance having dedicated hardware to enable cost-effective tracking.
A biopsy can be described as a minimally invasive procedure where a sample of tissue is obtained for ex vivo pathologic analysis. Typically, a biopsy device (or biopsy gun) can comprise an inner stylet and outer hollow cannula, both of which can be attached to the biopsy gun handle. In many instances, the biopsy gun can be a disposable device. A typical biopsy device can be positioned in tissue under some form of image guidance (typically ultrasound (US)) and then ‘fired’. The act of firing generally first deploys the inner stylet and then the outer cannula in quick succession, thus capturing a tissue sample in the slot of the inner stylet. The actual location of the biopsy sample can be offset from the resting position of the biopsy device prior to firing.
In many biopsy procedures, disposable biopsy guns are employed. Since these are typically designed for one-time use only, incorporating ultrasound sensing technology along with its amplifying and noise-cancelling electronics on these guns can be complex and relatively expensive.
In accordance with the present principles, a system for tracking a medical device includes an introducer. Two or more sensors are disposed along a length of the introducer and are spaced apart along the length. An interface is configured to connect to the introducer such that the introducer and the interface operatively couple to and support the medical device wherein the two or more sensors are configured to provide feedback for positioning and orienting the medical device using medical imaging.
Another system for tracking a medical device includes an introducer, and two or more sensors disposed along a length of the introducer and being spaced apart along the length. An interface is configured to connect to the introducer such that the introducer and the interface operatively couple to and support the medical device wherein the two or more sensors are configured to provide feedback for positioning and orienting the medical device. An interpretation module is configured to receive the feedback and generate image information for indicating a position and orientation of the introducer in an image.
A method for tracking a medical device includes providing an introducer with two or more sensors disposed along a length of the introducer and being spaced apart along the length, the introducer being coupled to an interface; operatively supporting the medical device by the introducer and the interface; and receiving signals from a subject by the two or more sensors which are configured to provide feedback for positioning and orienting the medical device in a medical image.
These and other objects, features and advantages of the present disclosure will become apparent from the following detailed description of illustrative embodiments thereof, which is to be read in connection with the accompanying drawings.
This disclosure will present in detail the following description of preferred embodiments with reference to the following figures wherein:
In accordance with the present principles, a biopsy introducer is provided that includes one or more ultrasound sensors. The introducer may include disposable and/or non-disposable configurations. In one embodiment, an interface clip is provided that attaches the introducer to a biopsy gun handle. The exemplary interface clip can be configured to retrofit multiple biopsy gun handles in an ergonomic manner. For example, in accordance with exemplary embodiments, an interface clip can be non-disposable (e.g., reusable) and/or disposable. In an exemplary non-disposable version, the interface clip can include adaptor electronics (e.g., amplifying and noise-cancelling electronics). The exemplary introducer in this case can be either non-disposable or disposable.
In accordance with another exemplary embodiment, the interface clip can be disposable. In such a case, the exemplary introducer and interface clip can be combined into a single hardware design (device), since they can both be disposable. The interface clip does not need to include the adaptor electronics, as the adaptor electronics can be housed separately. Benefits of exemplary embodiments can include, but are not limited to, no requirement to sterilize the adaptor, since, e.g., the adaptor may not come in contact with the patient. In one embodiment, the interface clip can be attached to the biopsy gun handle. Other embodiments can be commercialized independently and made compatible with multiple disposable biopsy needles on the market.
In accordance with exemplary embodiments, dedicated hardware can be employed to enable cost-effective tracking of a needle or other device. InSitu technology can be utilized for biopsy procedures, without modifying the biopsy gun design. InSitu technology can be employed with commercially available biopsy guns, for example. A modular design can interface with the biopsy gun using a combination of non-disposable and/or disposable hardware to employ.
It should be understood that the present invention will be described in terms of medical instruments; however, the teachings of the present invention are much broader and are applicable to any trackable instruments. In some embodiments, the present principles are employed in tracking or analyzing complex biological or mechanical systems. In particular, the present principles are applicable to internal tracking procedures of biological systems and procedures in all areas of the body such as the lungs, gastro-intestinal tract, excretory organs, blood vessels, etc. The elements depicted in the FIGS. may be implemented in various combinations of hardware and software and provide functions which may be combined in a single element or multiple elements.
The functions of the various elements shown in the FIGS. can be provided through the use of dedicated hardware as well as hardware capable of executing software in association with appropriate software. When provided by a processor, the functions can be provided by a single dedicated processor, by a single shared processor, or by a plurality of individual processors, some of which can be shared. Moreover, explicit use of the term “processor” or “controller” should not be construed to refer exclusively to hardware capable of executing software, and can implicitly include, without limitation, digital signal processor (“DSP”) hardware, read-only memory (“ROM”) for storing software, random access memory (“RAM”), non-volatile storage, etc.
Moreover, all statements herein reciting principles, aspects, and embodiments of the invention, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents as well as equivalents developed in the future (i.e., any elements developed that perform the same function, regardless of structure). Thus, for example, it will be appreciated by those skilled in the art that the block diagrams presented herein represent conceptual views of illustrative system components and/or circuitry embodying the principles of the invention. Similarly, it will be appreciated that any flow charts, flow diagrams and the like represent various processes which may be substantially represented in computer readable storage media and so executed by a computer or processor, whether or not such computer or processor is explicitly shown.
Furthermore, embodiments of the present invention can take the form of a computer program product accessible from a computer-usable or computer-readable storage medium providing program code for use by or in connection with a computer or any instruction execution system. For the purposes of this description, a computer-usable or computer readable storage medium can be any apparatus that may include, store, communicate, propagate, or transport the program for use by or in connection with the instruction execution system, apparatus, or device. The medium can be an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system (or apparatus or device) or a propagation medium. Examples of a computer-readable medium include a semiconductor or solid state memory, magnetic tape, a removable computer diskette, a random access memory (RAM), a read-only memory (ROM), a rigid magnetic disk and an optical disk. Current examples of optical disks include compact disk-read only memory (CD-ROM), compact disk-read/write (CD-R/W), Blu-Ray™ and DVD.
Further, it should be understood that any new computer-readable medium which may hereafter be developed should also be considered as computer-readable medium as may be used or referred to in accordance with exemplary embodiments of the present invention and disclosure.
Reference in the specification to “one embodiment” or “an embodiment” of the present principles, as well as other variations thereof, means that a particular feature, structure, characteristic, and so forth described in connection with the embodiment is included in at least one embodiment of the present principles. Thus, the appearances of the phrase “in one embodiment” or “in an embodiment”, as well any other variations, appearing in various places throughout the specification are not necessarily all referring to the same embodiment.
It is to be appreciated that the use of any of the following “/”, “and/or”, and “at least one of”, for example, in the cases of “A/B”, “A and/or B” and “at least one of A and B”, is intended to encompass the selection of the first listed option (A) only, or the selection of the second listed option (B) only, or the selection of both options (A and B). As a further example, in the cases of “A, B, and/or C” and “at least one of A, B, and C”, such phrasing is intended to encompass the selection of the first listed option (A) only, or the selection of the second listed option (B) only, or the selection of the third listed option (C) only, or the selection of the first and the second listed options (A and B) only, or the selection of the first and third listed options (A and C) only, or the selection of the second and third listed options (B and C) only, or the selection of all three options (A and B and C). This may be extended, as readily apparent by one of ordinary skill in this and related arts, for as many items listed.
It will also be understood that when an element such as, e.g., a layer, region or material is referred to as being “on” or “over” another element, it can be directly on the other element or intervening elements may also be present. In contrast, when an element is referred to as being “directly on” or “directly over” another element, there are no intervening elements present. It will also be understood that when an element is referred to as being “connected” or “coupled” to another element, it can be directly connected or coupled to the other element or intervening elements may be present. In contrast, when an element is referred to as being “directly connected” or “directly coupled” to another element, there are no intervening elements present.
Referring now to the drawings in which like numerals represent the same or similar elements and initially to
The tracking sensors 22 may include ultrasonic sensors although other types of sensors may be employed for tracking the needle 14.
In one embodiment, the introducer 20 is connected with an interface 32. The interface 32 connects the introducer 20 to a biopsy gun handle 24. The interface 32 may include adaptor electronics 26 therein. The adaptor electronics 26 may include noise cancellation modules 28 (software and/or hardware), amplifiers 30 and any another signal processing modules 34 needed to process received signals from sensors 22.
The sensors 22 function as ultrasound trackers. The introducer 20 and the sensors 22 may be disposable or non-disposable. In one embodiment, the ultrasound trackers for sensors 22 may include PZT, PVDF, or other piezoelectric element disposed between conductive plates or layers. The interface or interface clip 32 may be employed to attach the introducer 20 to the biopsy gun handle 24. The interface 32 may include the adaptor electronics 26 and be reusable (non-disposable). In another embodiment, the interface 32 may be made disposable. In another embodiment, the introducer 20 and interface 32 can be combined into a single disposable device. A sensor cable 36 can be provided (although wireless connections are also contemplated) as an output from the interface 32 and can be connected to an adaptor or other connector. The interface 32 may be reusable (non-disposable).
In one embodiment, the introducer 20 includes a hollow tube including one or more ultrasound trackers or sensors 22 that can be tracked using InSitu technology. The introducer 20 may have an inner diameter that is marginally thicker than the cannula 18, thereby permitting the cannula 18 and the stylet 16 to fit inside the introducer 20. The length of the introducer 20 can be approximately equal to the length of the needle 16 in its resting position prior to firing. If at least two sensors 22 are employed, the orientation of the introducer 20 (and also the cannula 18 and stylet 16) can be estimated. Therefore, the biopsy location coordinates can be computed prior to firing.
The biopsy system 10 may work in conjunction with or be integrated in a workstation or console 42 from which a procedure is supervised and/or managed. Workstation 42 preferably includes one or more processors 44 and memory 46 for storing programs and applications. Memory 46 may store an interpretation module 45 configured to interpret feedback signals from sensors 22. Interpretation module 45 is configured to employ the signal feedback (and any other feedback, e.g., electromagnetic (EM) tracking) to reconstruct position and orientation of the introducer 20 or other medical device or instrument. The other medical devices may include a catheter, a guidewire, a probe, an endoscope, a robot, an electrode, a filter device, a balloon device, or other medical component, etc.
In one embodiment, workstation 42 includes an image processing module 48 configured to receive feedback from the sensors 22 and further process the information to determine position and orientation of the introducer 20 within a volume (subject) 54. An image 50 for the space or volume 54 can be generated and displayed on a display device 52 that indicates the position and orientation of the introducer 20 (and other components) in a live image.
Interpretation module 45 can also be configured to determine an estimated position of where a biopsy sample will be taken in the subject 54. The interpretation module 45 may convey this information to the image processing module 48 to generate an image showing a location of the estimated position to assist a user. The image may include a line or other shape to provide a visual indicator (see
Workstation 42 includes the display 52 for viewing internal images of a subject (patient) or volume 54 and may include the image as an overlay or other rendering of the sensors 22, introducer 20, needle 14, etc. Display 52 may also permit a user to interact with the workstation 42 and its components and functions, or any other element within the system.
This is further facilitated by an interface 60 which may include a keyboard, mouse, a joystick, a haptic device, or any other peripheral or control to permit user feedback from and interaction with the workstation 42.
An imaging system 70 is provided for imaging the introducer 20 for guidance and positioning. In one embodiment, the imaging system 70 includes an ultrasound imaging system, which employs an imaging probe 72. The imaging probe 72 provides ultrasonic energy, which is received by the sensors 20. The sensors 20 are electrically connected (by wires, not shown, or wirelessly) to the adaptor electronics 26 for signal processing and amplification. The adaptor electronics 26 may in turn be connected to the workstation 42 where the interpretation module 45 further processes the signals, registers the introducer 20 (and other components) to the images collected by the imaging system 70. While the imaging system 70 is described as an ultrasound imaging system 70, other imaging technologies may be employed.
Referring to
The sensors 22 may include ultrasound sensors. In this case, an ultrasound probe transmits signals that are received by the sensors 22. Using time of flight information and knowledge of the coordinate system of the subject, positions of the sensors 22 (and therefore introducer 20 and the needle 14) can be determined in the ultrasound space and the estimated location 104 determined.
In a second instance 110, the inner stylet 16 is fired. The inner stylet 16 rapidly advances to the throw extent to capture a biopsy sample in a chamber 106 of the inner stylet 16 that corresponds with the estimated position 104. In a third instance 120, the outer cannula 18 is advanced to shear off the biopsy sample in the chamber 106 and enclose the chamber 106 to safely remove the biopsy sample from the subject.
Referring to
The biopsy gun 212 is configured for needle tracking. The biopsy gun 212 includes a biopsy needle 214 having an inner stylet 216 disposed within an outer cannula 218 as described above. The needle 214 is, in turn, disposed within the introducer 220, which may include a hollow tube introducer 220 to encapsulate the needle 214. The introducer 220 includes one or more tracking sensors 222 (e.g., on the inside diameter of the tube, although the sensors 222 may be mounted on an exterior of the introducer 220). The tracking sensors 222 may include ultrasonic sensors although other types of sensors may be employed for tracking the needle 214.
In one embodiment, the introducer 220 may be integrally formed with the interface 232 or the interface 232 may be a separate part that connects to the introducer 220. The interface 232, since it is disposable, may or may not include adaptor electronics therein. The adaptor electronics may be included in a separate module 228 for noise cancellation, amplifiers, etc. to process received signals from sensors 222.
The sensors 222 may include one or more ultrasound trackers. The introducer 220 and the sensors 222 may be disposable. In one embodiment, the ultrasound trackers for sensors 222 may include PZT, PVDF, or other piezoelectric element disposed between conductive plates or layers. The interface 232 may be employed to attach the introducer 220 to the biopsy gun handle 224. The interface 232 may include the adaptor electronics and be reusable (non-disposable), although a disposable embodiment may include a reusable adaptor electronics module 228. In this instance, the interface 232 is disposable and the adaptor electronics 228 are not disposable. A cable 234 can be provided as an output from the sensors 222 and can be connected to the adaptor electronics module 228 or other connector or system, e.g., a system employing InSitu technology (see e.g.,
The interface 232 may include an opening 240 to receive the introducer 220. When the introducer 220 is fitted into the interface 232, an electrical connection is completed between a wire or wires of the sensors 220 through the introducer 220 and to the cable 234 from the interface 232. The introducer 220 can be disposable or non-disposable with the sensors 222 and their wiring. The adaptor electronics can then be housed separately (module 228) so that it does not come in contact with the subject (e.g., the patient).
Referring again to
The sensors 22, 222 on the introducer 20, 220 passively listen to the ultrasound waves impinging on them as the imaging probe's beams sweep the field of view. Analysis of these signals yields the position of the sensor 22, 222 on the introducer 20, 220 in the frame of reference of the ultrasound image. The position can then be overlaid on an ultrasound image for enhanced visualization, and the positions and their histories can be logged for tracking, segmentation, and other applications.
Embodiments in accordance with the present principles can be made compatible with multiple biopsy needles on the market. In addition, the introducers described herein may be employed in procedures other than biopsy procedures. For example, the present principles may be employed for ablation needle guidance, catheter guidance, endoscopic procedures, etc. Moreover, it is contemplated that corresponding and/or related systems incorporating and/or implementing the present principles are also contemplated and considered to be within the scope of the present invention. Further, corresponding and/or related methods for manufacturing and/or using a device and/or system in accordance with the present disclosure are also contemplated and considered to be within the scope of the present invention.
Referring to
In block 310, signals are received from a subject by the two or more sensors, which are configured to provide feedback for positioning and orienting the medical device in a medical image. In block 312, the feedback signals are processed using adaptor electronics configured to connect to the sensors and provide noise cancellation, amplify the signals, filter the signals, etc.
In block 314, the introducer and therefore the medical device is positioned in a field of view of an image and aligned with a biopsy sample or other target using the feedback signals.
In block 316, the medical device may include a biopsy gun including a needle with an inner stylet and an outer cannula. An estimate position of a biopsy sample may be determined based upon a position and orientation of the introducer. The estimate position may be manually determined or may be computed using an interpretation module (
In interpreting the appended claims, it should be understood that:
Having described preferred embodiments for ultrasound tracking apparatus for disposable biopsy needles (which are intended to be illustrative and not limiting), it is noted that modifications and variations can be made by persons skilled in the art in light of the above teachings. It is therefore to be understood that changes may be made in the particular embodiments of the disclosure disclosed which are within the scope of the embodiments disclosed herein as outlined by the appended claims. Having thus described the details and particularity required by the patent laws, what is claimed and desired protected by Letters Patent is set forth in the appended claims.
This application is a Continuation of application Ser. No. 15/324,137, filed Jan. 5, 2017 which is the U.S. National Phase application under 35 U.S.C. § 371 of International Application No. PCT/IB2015/055352, which claims priority to provisional application Ser. No. 62/025,480, filed on Jul. 16, 2014. These applications are hereby incorporated by reference herein.
Number | Date | Country | |
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62025480 | Jul 2014 | US |
Number | Date | Country | |
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Parent | 15324137 | Jan 2017 | US |
Child | 17546202 | US |