Integrated sensor on biopsy tool

Abstract

This disclosure is directed to a device, including a tube, a needle located partially within the tube, the needle including a sensor, and a sheath covering an interconnection of the needle and the tube.

Description

INTEGRATED SENSOR ON BIOPSY TOOLBACKGROUNDTechnical Field

[0001] The present disclosure relates to the field of navigating medical devices within a patient, and in particular, tracking a position of medical devices within the luminal network and relative to a target.Description of Related Art

[0002] There are several commonly applied medical methods, such as endoscopic procedures or minimally invasive procedures, for treating various maladies affecting organs including the liver, brain, heart, lungs, gall bladder, kidneys, and bones. Often, one or more imaging modalities, such as magnetic resonance imaging (MRI), ultrasound imaging, computed tomography (CT), cone-beam computed tomography (CBCT) or fluoroscopy (including 3D fluoroscopy) are employed by clinicians to identify and navigate to areas of interest within a patient and ultimately a target for biopsy or treatment. In some procedures, pre-operative scans are utilized for target identification and intraoperative guidance. For example, in an endoscopic approach, navigating to areas of interest within a patient is enabled with the use of previously acquired MRI data or CT image data that has been used to generate a three-dimensional (3D) rendering, model, or volume of the particular body part such as the lungs. The 3D model provides guidance including pathway plans that are displayed in the 3D model to navigate the luminal network and arrive at an identified target that is also displayed in the 3D model.

[0003] However, because among other things, there is often a delay between the timing of the MRI or CT imaging, and the actual procedure, there can be divergence between real-time shape and orientation of the luminal network of the patient and the shapes of the luminal network depicted in the 3D model. This is commonly referred to as CT-to-body divergence.

[0004] To address some aspects of CT-to-body divergence real-time images such as from a fluoroscope or a cone beam CT imager can be acquired. The real-time images provide a more accurate and current image of the target area and particularly of the relative distance and orientation of the medical device and the target area. This real-time imaging helps assure the clinician that they are navigating the medical device to a target in a safe and accurate manner (e.g., without causing damage to other organs or tissue).

[0005] Often during an intraluminal navigation procedure, following navigation of a catheter to a desired location, a medical device such as a biopsy or therapy tool is inserted into the catheter to perform the biopsy or therapy procedure. As can be appreciated, advancement of medical devices, such as a biopsy tool or therapy tool, which typically have a rigid or substantially rigid display portion can may cause a distal end of the catheter to deflect or otherwise deviate from the position to which it was navigated. The deviation of the medial device from the intended pathway may result in inaccurate samples being obtained or unintended damage to surrounding tissues.

[0006] Accordingly, further intraprocedural imaging (e.g., fluoroscopic images) may be required to identify the position, orientation, and trajectory of the medical device relative to target tissue before proceeding to acquire a biopsy sample or to treat the target tissue. As can be appreciated, the use of two-dimensional fluoroscopy images leads to additional procedure time and radiation exposure. Further the two-dimensional fluoroscopy images can be challenging to accurately in the three-dimensional environment of the patient. Accordingly, improvements to existing systems and methods are required.SUMMARY

[0007] One aspect of the disclosure is directed to a device including a tube, a needle located partially within the tube, the needle including a sensor, and a sheath covering an interconnection of the needle and the tube.

[0008] Implementations may include one or more of the following features. The device may include a twisted pair of wires extending from the needle sensor. The twisted pair of wires are located within a channel of the needle. The sensor is a micro coil sensor located in a pocket of the needle. The sensor includes windings of wire wound around a portion of the needle. The sensor is a tunneling magnetoresistance sensor. The needle includes attachment features securing the needle to the tube. The attachment features include one or more of fins, machine marks, or a roughened surface. The tube may include a polymeric material. The tube may include two or more layers of polymeric material. The device may include a twisted pair of wires extending from the sensor between two layers of polymeric material. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium.

[0009] Another aspect of the disclosure is directed to a system including a catheter having a first sensor; a device configured for insertion through the catheter, the device including a second sensor; a tracking system configured to detect a location of the first sensorand the second sensor. The system also includes a memory storing an application, where execution of the application on a processor: displays a three-dimension (3D) model of a luminal network of a patient; displays, in the 3D model, a representation of a distal portion of the catheter at a detected position of the first sensor; displays, in the 3D model, a representation of the medical device at a detected position of the second sensor; and displays, in the 3D model, a target for placement of the medical device. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.

[0010] Implementations may include one or more of the following features. The system where the application when executed by the processor receives intra-procedural images and performs a local registration to update a relative position of the displayed representation of the distal portion of the catheter and the target in the 3D model. The medical device includes a needle connected to a distal portion of a tube, and where the second sensor is located in the needle. The system may include a twisted pair of wires extending from the second sensor. The twisted pair of wires are located within a channel of the needle. The sensor is a micro coil sensor located in a pocket of the needle, or includes windings of wire wound around a portion of the needle, or is a tunneling magnetoresistance sensor. The second sensor is located in a stylet. The stylet is insertable into a lumen of the device. The stylet extends beyond a distal end of the device and prevents tissue from entering the device. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Various aspects and embodiments of the disclosure are described hereinbelow with references to the drawings, wherein:

[0012] FIG. 1 is a schematic view of a surgical system provided in accordance with the disclosure;

[0013] FIG. 2A is a side cross-sectional view of a medical device in accordance with the disclosure;

[0014] FIG. 2B is a side cross-sectional view of a medical device in accordance with the disclosure;

[0015] FIG. 2C is a cross-sectional view of the medical device of FIGs. 2A and 2B in accordance with aspects of the disclosure;

[0016] FIG. 3 is a side view of a medical device in accordance with the disclosure;

[0017] FIG. 4 is a side view of a medical device in accordance with the disclosure;

[0018] FIG. 5 is a flow chart depicting a method in accordance with the disclosure; and

[0019] FIG. 6 is a schematic diagram of a system in accordance with the disclosure.DETAILED DESCRIPTION

[0020] The disclosure is directed to medical devices (e.g., biopsy tools, biopsy forceps, ablation catheters, and others) configured for insertion into and extension from a catheter navigated to a desired location within a luminal network. Current methodologies for intraluminal navigation employ the use of multiple rounds of fluoroscopic (or other modalities) imaging to confirm position and orientation of an intraluminal catheter or a medical device relative to a target for biopsy or therapy and during the biopsy or therapy to ensure effective and accurate sampling or treatment. Accordingly, improvements to existing systems and methods are desirable.

[0021] One aspect of the disclosure is directed to incorporation of one or more sensors in a distal portion of the medical devices. In one example, an electromagnetic (EM) sensor is incorporated in the distal portion of the medical device. As the medical device is advanced to and beyond the distal end of the catheter, the rigidity of the medical device (e.g., needle portion of a biopsy tool) can cause the catheter to deflect. By incorporation of a sensor in the medical device, a clinician can observe the changes in location of the catheter, which also incorporates position sensors, and differences between a planned position and trajectory of the medical device and a real trajectory of the medical device as it exits the catheter. By observing these differences, and with knowledge of the actual position, orientation, and trajectory of the medical device relative to a target, adjustments can be undertaken to the position and orientation of the catheter to ensure that an effective biopsy sample is acquired, a therapy device is accurately placed, and critical structures are avoided. All of this can thus be achieved without, or at least with limited fluoroscopic imaging being required.

[0022] FIG. 1 is a perspective view of an exemplary system for facilitating navigation of a medical device (e.g., a catheter) to a soft tissue target via airways of the lungs. As shown in FIG. 1, catheter 102 is part of a catheter guide assembly 106. In one embodiment, catheter 102 is inserted into a bronchoscope 108 for access to a luminal network of the patient P. Specifically, catheter 102 of catheter guide assembly 106 may be inserted into a working channel of bronchoscope 108 for navigation through a patient’s luminal network. The catheter 102 may itself include imaging capabilities via an integrated camera or opticscomponent 109 and a separate bronchoscope 108 is not strictly required. A locatable guide (LG) 110 (a second catheter), including a sensor 104 may be optionally inserted into catheter 102 and locked into position such that sensor 104 extends a desired distance beyond the distal tip of catheter 102. The position and orientation of sensor 104 relative to a reference coordinate system, and thus the distal portion of catheter 102, within an electromagnetic field can be derived. Catheter guide assemblies 106 are currently marketed and sold by Medtronic PLC under the brand names SUPERDIMENSION® Procedure Kits, or EDGE™ Procedure Kits, and are contemplated as useable with the disclosure.

[0023] System 100 generally includes an operating table 112 configured to support a patient P. Monitoring equipment is coupled to bronchoscope 108 or catheter 102 (e.g., a video display 114, for displaying the video images received from the video imaging system of bronchoscope 108 or the catheter 102); a locating or tracking system 115 including a locating module 116, a plurality of reference sensors 118 and a transmitter mat 120 including a plurality of incorporated markers (not shown). A computing device 122 includes software and / or hardware used to facilitate identification of a target, pathway planning to the target, navigation of a medical device to the target, and / or confirmation and / or determination of placement of catheter 102, or a suitable device therethrough, relative to the target.

[0024] Catheter guide assembly 106 can be navigated within the patient and the tracking system 115 (e.g., a six degrees-of-freedom electromagnetic tracking system, or other suitable system for determining position and orientation of a distal portion of the catheter 102) is utilized, to detect a position of the sensor 104 and register the patient’s lungs with a 3D model generated from, for example, a CT or MRI image scan. As described above, locatable guide 110 and sensor 104 are configured for insertion through catheter 102 into patient P’s airways (either with or without bronchoscope 108) and are selectively lockable relative to one another via a locking mechanism.

[0025] Transmitter mat 120 is positioned beneath patient P. Transmitter mat 120 generates an electromagnetic field around at least a portion of the patient P within which the position of a plurality of reference sensors 118 and the sensor 104 can be determined with use of a tracking module 116. A second (and optionally a third) electromagnetic sensor 126 may also be incorporated into the end of the catheter 102. The second electromagnetic sensors 126 may be a five degree-of-freedom sensor or a six degree-of-freedom sensor. These sensors 126 can be employed to determine a location and orientation of a distal portion of the catheter 102 even when the LG 110 with sensor 104 have been removed from the catheter. Further,the sensors 126 enable use of the catheter guide assembly 106 without requiring the LG 110 and sensor 104.

[0026] One or more of reference sensors 118 are attached to the chest of the patient P. Registration is generally performed to coordinate locations of the three-dimensional model and two-dimensional images from a procedure planning phase in which a pathway and targets for biopsy or therapy are defined, with the patient P’s airways. Such planning and registration allows for a navigation phase to be undertaken with in conjunction with detection of the location of the sensors 104 or 126 as they are navigated within the luminal network.

[0027] Registration of the patient P’s location on the transmitter mat 120 may be performed by moving sensor 104 or 126 through the airways of the patient P. More specifically, data pertaining to locations of sensor 104 or 126 within an electromagnetic field generate by the transmitter mat 120 as the sensor 104 or 126 is moving through the airways, is recorded using the tracking system 115 and with reference to the locations of the reference sensors 118. A shape resulting from this location data is compared to an interior geometry of passages of a 3D model, and a location correlation between the shape and the 3D model based on the comparison is determined, e.g., utilizing the software on computing device 122. In addition, the software identifies non-tissue space (e.g., air filled cavities) in the three- dimensional model. The software aligns, or registers, an image representing a location of sensor 104 with the three-dimensional model and / or two-dimensional images generated from the three-dimension model, which are based on the recorded location data and an assumption that sensors 104 or 126 remain located in non-tissue space in patient P's airways. Alternatively, a manual registration technique may be employed by navigating the sensors 104 or 126 to pre-specified locations in the lungs of the patient P, and manually correlating the images from the bronchoscope to the model data of the three-dimensional model.

[0028] Though described herein with respect to EMN systems using EM sensors, the instant disclosure is not so limited and may be used in conjunction with flexible sensors such as fiber-Bragg grating sensors, inertial measurement unit (IMU), ultrasonic sensors, or without sensors. Additionally, as outlined below the methods described herein may be used in conjunction with motorized or robotic systems such that robotic actuators drive and articulate the catheter 102 within the patient to the desired target.

[0029] In accordance with aspects of the disclosure, the visualization of intra-body navigation of a medical device (e.g., a biopsy tool or a therapy tool), towards a target (e.g., a lesion) may be a portion of a larger workflow of a navigation system. An imaging device 124(e.g., a fluoroscope or a CT or cone beam CT imaging device such as the Medtronic O-arm™ surgical imaging system) capable of acquiring 2D and 3D images or video of patient P is also included in this particular aspect of system 100. The images, sequence of images, or video captured by imaging device 124 may be stored within the imaging device 124 or transmitted to computing device 122 for storage, processing, and display. Additionally, imaging device 124 may move relative to the patient P so that images may be acquired from different angles or perspectives relative to patient P to create a sequence of images, such as a fluoroscopic video. The pose of imaging device 124 relative to patient P while capturing the images may be estimated via markers incorporated with the transmitter mat 120. The markers are positioned under patient P, between patient P and operating table 112 and between patient P and a radiation source or a sensing unit of imaging device 124. The markers incorporated with the transmitter mat 120 may be two separate elements which may be coupled in a fixed manner or alternatively may be manufactured as a single unit. Imaging device 124 may include a single imaging device or more than one imaging device.

[0030] Computing device 122 may be any suitable computing device including a processor and storage medium, wherein the processor is capable of executing instructions stored on the storage medium. Computing device 122 may further include a database configured to store patient data, CT data sets including CT images, fluoroscopic data sets including images and video, 3D reconstruction, navigation plans, and any other such data. Although not explicitly illustrated, computing device 122 may include inputs, or may otherwise be configured to receive, CT data sets, fluoroscopic images / video and other data described herein. Additionally, computing device 122 includes a display configured to display graphical user interfaces. Computing device 122 may be connected to one or more networks through which one or more databases may be accessed.

[0031] Though described herein in conjunction with a manually navigated catheter 102, the disclosure is not so limited and the features and methods described herein can be utilized in conjunction with one or more robotically navigated or mechanically driven catheter systems without departing from the scope of the disclosure.

[0032] As noted above, commercialization of a biopsy or therapy tool including a sensor has been severely limited. FIG. 2A depicts a distal end of a biopsy tool 200. The biopsy tool 200 includes a push tube 202 (e.g., a polymeric push tube) including a lumen 204 extending through the push tube 202. A needle 206 is connected to the distal end of the push tube 202. A sensor 208 is formed on the needle 206. As depicted in FIG. 2A the sensor 208 is formedof a wire 210 wrapped or wound around a portion of the needle 206 and the wire 210 extends from the sensor 208 as a twisted pair proximally from the needle 206. The twisted pair 212 extends to the proximal end of the biopsy tool where it electrically connects to the tracking system 115. The needle may be formed of a metal such as stainless steel.

[0033] On a proximal end of the needle 206 are a variety of attachment features 214. As shown in FIG. 2A the attachment features are a series of fins formed radially about the circumference of the needle. Additionally, or alternatively, mechanical features 216 including holes, slots, machine marks, and grit blasting (e.g., sand or soda), and others may be applied to the surface of the needle 206 to achieve, as depicted in FIG. 2B as a roughened surface 218, this roughened surface may be a series of machined ribs formed into the needle 206. The attachment features 214, mechanical features 216, and roughened surface 218 provide a roughened, sometimes irregular surface that receives a distal portion of the push tube 202 (or heat shrink sheath 220). For example, during manufacture, after placement of the push tube 202 (or heat shrink sheath 220) over the attachment features 214, mechanical features 216 or roughened surface 218, the push tube 202 (e.g., polymeric push tube) can be reflowed (heated above it’s reflow temperature). When push tube 202 cools, a mechanical interlock is formed between the portion of the push tube 202 that reflowed to fill any gaps between the push tube 202 and the needle 206. Similarly, the heat shrink sheath 220, when heated and shrunk onto the needle 206 is griped by the mechanical features 216 to secure it to the needle 206 and the push tube 202.

[0034] The heat shrink sheath 220 may be optionally placed over the interconnection 222 of the push tube 202 and the needle 206. The heat shrink sheath 220 provides an additional layer of protection preventing the needle 206 from separating from the push tube 202 and ensuring a smooth interruption free transition from the needle 206 to the push tube 202, and prevents the interconnection point 222 from snagging on a distal end of the catheter 102 or another object.

[0035] In FIG. 2A the push tube 202 may be formed of multiple layers of polymetric materials. During assembly the twisted pair 212 may be wrapped around an inner layer of polymeric material and a second layer of polymeric material placed overtop of the first layer and the twisted pair 212. Upon reflow of the polymeric materials the two layers fuse together trapping the twisted pair 212 there between. The formation of the wire 210 into a twisted pair negates any interference transmission that could be generated by the passage of an induced current from the sensor 208 to the tracking system 115.

[0036] FIG. 2 A depicts an air coil sensor, wherein the windings of wire 210 are wound around the needle 206 and an opening lumen 224 in the needle 206 into which biopsy samples are acquired, this lumen 224 extends to and is in fluid communication with the lumen 204 of the push tube 202 enabling aspiration, lavage, and application of therapeutics. Alternatively, FIG. 2B depicts a micro-coil sensor 208 placed in a pocket 226 formed in the needle 206. Rather than wrapping a wire 210 around the needle 206, the micro coil sensor 208 is formed separate from the needle 206. The micro coil sensor 208 may be potted in the pocket 226 and held in place by an adhesive or other potting material. Additionally, or alternatively, the sensor 208 may be a tunneling magnetoresistance (TMR) sensor. The TMR sensor may be potted in the pocket 226 or attached at other locations along the needle 206 or push tube 204. Similarly, one or more of the sensors 104 or 126 on the catheter 102 may be a TMR sensor without departing from the scope of the disclosure. The pocket 226 may include a channel 228 that extends through the attachment features 214. The push tube 202 is received on the attachment features 214 over the channel 228 and the twisted pair 212. FIG. 2C depicts the channel 228 formed in the needle 206 through which the twisted pair 212 passes. As with FIG. 2A, the lumen 224 in the needle 206 extends to and is in fluid communication with lumen 204 of the push tube 202. In both FIGS. 2A and 2B the sensor 208 does not interference with the application of suction to the lumen 224 or 204.

[0037] The biopsy tools 200 of FIGS. 2A and 2B provide a commercially viable methodology for connecting a sensor 208 to the biopsy tool 200. The needle 206 with sensor 208 and twisted pair 212 may be manufactured as a subassembly and then connected to the push tube 202 for reflow of the push tube 202 material. The heat shrink sheath 220 can be added either before or after the reflow and upon cooling, form and integrated biopsy tool 200 with sensor 208. Alternatively, the micro coil sensor 208 or TMR can be potted in the pocket 226 of the needle 206, and then joined to the push tube 202 via reflow.

[0038] As noted above, the passage of a biopsy tool such as the biopsy tools 200 depicted in FIGS. 2A-2C through a catheter 102 can change the position and orientation of a catheter 102. In part this is due to differences in stiffness of the biopsy tool 200, particularly the needle 206 as compared to the polymeric materials and flexible metal braid of the catheter 102. Though relatively short in length, the needle 206 is necessarily made of a stiff material, such as stainless steel, to allow the needle 206 to pierce tissue and collect a sample. Despite the relatively short length of the needle 206, its length still often exceeds the bend radius of many of the bends of the luminal network through which the catheter 102 and the biopsy tool200 are inserted. This difference causes the catheter 102 and, in some instances, the luminal network itself to change shape.

[0039] The position of biopsy tools 200 of FIGS. 2A-2C incorporating sensor 208 can be readily detected as the biopsy tool 200 passed through catheter 102 within a luminal network of a patient. With the position of the sensor 208 in the distal portion of the biopsy tool 200 determinations can be made regarding any change in position or orientation of the catheter 102 as a result of the insertion of the biopsy tool 200 into and through the catheter 102. This allows for repositioning of the catheter 102 prior to or during the emergence of the biopsy tool 200 from the distal end of the catheter 102 and prior to impacting any tissue. Further, determinations on a position, orientation, and trajectory of the biopsy tool 200 itself can be detected and adjusted during the collection of samples to ensure that the biopsy tool is aligned with target tissue from which a biopsy is desired. Further, any critical structures (e.g., blood vessels, pleura, etc.) can be avoided to reduce the potential for any inadvertent complications during the collection of the biopsy sample.

[0040] A further aspect of the disclosure is depicted in FIG. 3. Rather than forming the sensor 208 on the needle 206 of the biopsy tool 200, the sensor 208 is formed in a stylet 300. As is known in the art, many biopsy tools are inserted into a catheter 102, with a stylet 300 in place and extending beyond the distal end of the needle 206. The stylet 300 prevents the acquisition of tissue by the needle 206, until after the stylet 300 is retracted within the body of the biopsy tool 200, either or partially or completely to allow for application of aspiration and suction via the lumen of the biopsy tool 200. As will be appreciated, the stylet 300 also affects the stiffness of the biopsy tool 200 and therewith the stiffness of catheter 102 through which the combination may be placed within the body of a patient. Using the sensor 208 within the stylet 300, the biopsy tool 200 can be navigated through the catheter 102, and up to the target tissue for biopsy. A twisted pair of wires 212 extends proximally from the sensor 208 and connects to the tracking system 115. The position, orientation and trajectory of the catheter 102 can be adjusted and manipulated as the biopsy tool 200 with stylet 300 are inserted to maintain a desired position and orientation of the catheter 102. Detecting the position and orientation of the sensor 208 as the biopsy tool 200 is extended beyond the distal end of the catheter 102 ensures that the sample will be collected from the desired tissue and any critical structures are avoided.

[0041] While heretofore the disclosure has been directed to applications for use with biopsy tools, the disclosure is not so limited. FIG. 4 depicts a stylet 300 including a sensor208 removably inserted into an outer fluid channel 402 of a water jacketed microwave ablation catheter 400. Microwave ablation catheters 400 present a unique challenge when seeking to employ sensors 208. The microwave ablation catheter 400 includes a radiating section 401. In one example the radiating section 401 is a dipole antenna. The radiating section 401 is connected to a coated coaxial cable 404, which extends the length of the microwave ablation antenna 400. A proximal radiating section 406 is formed by removal of the coating from the coaxial cable 402 exposing the outer conductor 408. A feed gap 410 is formed by the removal of the outer conductor 408 exposing an insulating layer separating the outer conductor 408 from a center conductor (not shown). A distal radiating section 412 butts against the feed gap 410 and is connected to the center conductor of the coaxial cable 402. Microwave ablation catheter 400 is water jacketed, meaning that water flows through outer fluid channel 402, towards a distal end of the microwave ablation catheter 400 and then back through a center channel 403 in which the radiating section 401 and the coaxial cable 402 are located.

[0042] As with biopsy, accurate placement of a microwave ablation catheter 400 for treatment of a tumor or lesion is quite important. The dipole antenna configuration generates a substantially spherical ablation site around the radiating section 401. Often it is desirable to place the microwave ablation catheter 400 in or near a center of a tumor or lesion. Such placement allows for the application of energy through the radiating section 401 to the tissue to create sufficient margin around the tumor or lesion ensuring that the entire lesion or tumor has been treated without unnecessarily treating healthy tissue.

[0043] Prior attempts at incorporating sensors into a microwave ablation catheter have met challenges. Incorporation of permanent sensors into the microwave ablation catheter 400 have been associated with interference from the microwave ablation antenna impacting detection of the sensor’s location. Further emission of microwave energy can result in coupling of the sensor and antenna leading to induced currents in the sensor (or transmitter mat 120) and ultimately failure of one or more of the sensor, the antenna, or the transmitter mat 120. In accordance with the disclosure, many of the drawbacks of prior systems are addressed herein by the ability to remove the stylet 300 (and sensor 208) from the microwave ablation catheter 400 prior to application of energy to the microwave ablation catheter 400.

[0044] Though described in conjunction with FIG. 4 as a microwave ablation catheter 400, the catheter 400 could also be a radio-frequency ablation catheter, a cryo-ablation catheter, or a chemical ablation catheter enabling the application of these therapies, whileaccurately tracking the location and orientation of the distal end of the catheter within the body. Further, the fluid channel 402 may alternatively be gas channel used in cryo-ablation. Further, in the case of cryo-ablation and chemical ablation, the stylet 300 may remain within the catheter 400 during the application of therapy.

[0045] As will be appreciated with respect to the embodiments of FIGS 3 and 4, the stylet 300 is a reuseable component. The stylet 300 may be sterilized after each use and reused in the next procedure. The reuse of the stylet reduces the capital costs associated with disposable instruments.

[0046] FIG. 5 depicts a method 500 for use of medical devices (biopsy and therapy tools) in accordance with aspects of the disclosure. At step 502, following navigation of a catheter 102 to a desired location within the patient (e.g., within about 3 cm of a tumor or lesion) a local registration may be performed. A local registration may be for example the acquisition of fluoroscopic images from a sweep of a fluoroscope. The relative location and orientation of a distal portion of the catheter 102 and the target tissue (e.g., tumor or lesion) is determined with reference to the fluoroscopic images and a three-dimensional fluoroscopic volume generated from the fluoroscopic images. Once the relative position and orientation of the catheter 102 and the target (e.g., tumor or lesion) is determined, a 3D model generated from pre-procedural or intra-procedural CT images can be updated to accurately depict the relative position and orientation of the catheter 102 to the location of the and the target (e.g., tumor or lesion). As noted above, the local registration process is one method of eliminating CT-to-body divergence. Once the relative position of the catheter 102 is determined, at step 504 a medical device (e.g., biopsy tool 200 or ablation catheter 400) is tracked as it passes through the catheter 102. At step 506 the medical device is tracked using sensor 208 and a representation of the medical device’s movement towards the target is updated on the display 114. The medical can be tracked as it inserted the representation of the tumor or lesion in the 3D model while the medical device for acquisition of a biopsy or application of therapy. As a result, changes in position and orientation of the catheter 102 and changes in potential trajectory of the medical device can be observed in the display.

[0047] At step 508 a determination is made made whether the position or orientation of the catheter 102 has changed as a result of the insertion of the medical device. If yes, the catheter 102 can be repositioned or reoriented to a desired location and orientation relative to the target at step 510. If no, the stylet 300, if employed, can be optionally removed from the medical device at step 512.

[0048] In this manner, no further imaging steps other than the local registration is required to confidently position the catheter 102 and medical device to enable acquisition of a biopsy sample or place a therapy tool. At step 514, the medical device is tracked as it extends from the catheter 102 and is inserted into the target for performance of a procedure (e.g., biopsy or therapy). At step 516, a determination is made whether the trajectory of the medical device to a desired point in the target is maintained. If not, then the method returns to step 510 and the catheter 102 can be repositioned. If the trajectory is maintained, then at step 518 a determination is made whether the procedure is complete. If the procedure is not complete the method returns to step 514 where the trajectory of the medical device is tracked into the target. If the procedure is complete the method progresses to step 520 for a determination of whether there are more targets (e.g., for biopsy or therapy). If there are more targets the catheter 102 is navigated a desired location near the additional tumor or lesion and the method returns to step 502. to method returns to step 502, if not the method ends.

[0049] Reference is now made to FIG. 6, which is a schematic diagram of a system 600 configured for use with the methods of the disclosure including the method of FIG. 5. System 600 may include a workstation 601, and optionally an imaging device 615 (e.g., a fluoroscope, CT imaging device, or an ultrasound imaging device). In some embodiments, workstation 601 may be coupled with imaging device 615, directly or indirectly, e.g., by wireless communication. Workstation 601 may include a memory 602, a processor 604, a display 606 and an input device 610. Processor or hardware processor 604 may include one or more hardware processors. Workstation 601 may optionally include an output module 612 and a network interface 608. Memory 602 may store an application 618 and image data 614. Application 618 may include instructions executable by processor 604 for executing the methods of the disclosure including the method of FIG. 5.

[0050] Application 618 may further include a user interface 616. Image data 614 may include the CT scans, the generated fluoroscopic 3D reconstructions of the target area and / or any other fluoroscopic image data and / or the generated one or more slices of the 3D reconstruction. Processor 604 may be coupled with memory 602, display 606, input device 610, output module 612, network interface 608 and imaging device 615. Workstation 601 may be a stationary computing device, such as a personal computer, or a portable computing device such as a tablet computer. Workstation 601 may embed a plurality of computer devices.

[0051] Memory 602 may include any non-transitory computer-readable storage media for storing data and / or software including instructions that are executable by processor 604 and which control the operation of workstation 601 and, in some embodiments, may also control the operation of imaging device 615. Imaging device 615 may be used to capture a sequence of fluoroscopic images based on which the fluoroscopic 3D reconstruction is generated and to capture a live 2D fluoroscopic view according to this disclosure. In an embodiment, memory 602 may include one or more storage devices such as solid-state storage devices, e.g., flash memory chips. Alternatively, or in addition to the one or more solid-state storage devices, memory 602 may include one or more mass storage devices connected to the processor 604 through a mass storage controller (not shown) and a communications bus (not shown).

[0052] Although the description of computer-readable media contained herein refers to solid-state storage, it should be appreciated by those skilled in the art that computer-readable storage media can be any available media that can be accessed by the processor 604. That is, computer readable storage media may include non-transitory, volatile, and non-volatile, removable and non-removable media implemented in any method or technology for storage of information such as computer-readable instructions, data structures, program modules or other data. For example, computer-readable storage media may include RAM, ROM, EPROM, EEPROM, flash memory or other solid-state memory technology, CD-ROM, DVD, Blu-Ray or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which may be used to store the desired information, and which may be accessed by workstation 601.

[0053] Application 618 may, when executed by processor 604, cause display 606 to present user interface 616. User interface 616 may be configured to present to the user a single screen including a three-dimensional (3D) view of a 3D model of a target from the perspective of a tip of a medical device, a live two-dimensional (2D) fluoroscopic view showing the medical device, and a target mark, which corresponds to the 3D model of the target, overlaid on the live 2D fluoroscopic view. User interface 616 may be further configured to display the target mark in different colors depending on whether the medical device tip is aligned with the target in three dimensions.

[0054] Network interface 608 may be configured to connect to a network such as a local area network (LAN) consisting of a wired network and / or a wireless network, a wide area network (WAN), a wireless mobile network, a Bluetooth network, and / or the Internet. Network interface 708 may be used to connect between workstation 601 and imaging device615. Network interface 708 may also be used to receive image data 614. Input device 610 may be any device by which a user may interact with workstation 601, such as, for example, a mouse, keyboard, foot pedal, touch screen, and / or voice interface. Output module 612 may include any connectivity port or bus, such as, for example, parallel ports, serial ports, universal serial busses (USB), or any other similar connectivity port known to those skilled in the art. From the foregoing and with reference to the various figures, those skilled in the art will appreciate that certain modifications can be made to the disclosure without departing from the scope of the disclosure.

[0055] Aspects of this disclosure may be further described by reference to the following numbered examples:

[0056] Example 1. A device, including a tube, a needle located partially within the tube, the needle including a sensor, and a sheath covering an interconnection of the needle and the tube.

[0057] Example 2. The device of example 1, further comprising a twisted pair of wires extending from the needle sensor.

[0058] Example 3. The device of example 2, wherein the twisted pair of wires are located within a channel of the needle.

[0059] Example 4. The device of any of examples 1-3, wherein the sensor is a micro coil sensor located in a pocket of the needle.

[0060] Example 5. The device of any of examples 1-3, wherein the sensor includes windings of wire wound around a portion of the needle.

[0061] Example 6. The device of any of examples 1-3 wherein the sensor is a tunneling magnetoresistance sensor.

[0062] Example 7. The device of any of examples 1-6, wherein the needle includes attachment features securing the needle to the tube.

[0063] Example 8. The device of example 7, wherein the attachment features include one or more of fins, machine marks, or a roughened surface.

[0064] Example 9. The device of any of examples 1-8, wherein the tube comprises a polymeric material.

[0065] Example 10. The device of any of examples 1-9, wherein the tube comprises two or more layers of polymeric material.

[0066] Example 11. The device of example 10, further comprising a twisted pair of wires extending from the sensor between two layers of polymeric material.

[0067] Example 12. A system including, a catheter having a first sensor, a device configured for insertion through the catheter, the device including a second sensor, a tracking system configured to detect a location of the first sensor and the second sensor, and a memory storing an application, wherein execution of the application on a processor displays a three-dimension (3D) model of a luminal network of a patient, displays, in the 3D model, a representation of a distal portion of the catheter at a detected position of the first sensor, displays, in the 3D model, a representation of the medical device at a detected position of the second sensor, and displays, in the 3D model, a target for placement of the medical device.

[0068] Example 13. The system of example 12, wherein the application when executed by the processor receives intra-procedural images and performs a local registration to update a relative position of the displayed representation of the distal portion of the catheter and the target in the 3D model.

[0069] Example 14. The system of any of examples 12-13, wherein the medical device includes a needle connected to a distal portion of a tube, and wherein the second sensor is located in the needle.

[0070] Example 15. The system of example 14, further comprising a twisted pair of wires extending from the second sensor.

[0071] Example 16. The system of example 15, wherein the twisted pair of wires are located within a channel of the needle.

[0072] Example 17. The system of any of examples 14-16, wherein the sensor is a micro coil sensor located in a pocket of the needle, or includes windings of wire wound around a portion of the needle, or is a tunneling magnetoresistance sensor.

[0073] Example 18. The system of example 12, wherein the second sensor is located in a stylet.

[0074] Example 19. The system of example 18, wherein the stylet is insertable into a lumen of the device.

[0075] Example 20. The system of example 19, wherein the stylet extends beyond a distal end of the device and prevents tissue from entering the device.

[0076] Although embodiments have been described in detail with reference to the accompanying drawings for the purpose of illustration and description, it is to be understood that the inventive processes and apparatus are not to be construed as limited. It will be apparent to those of ordinary skill in the art that various modifications to the foregoing embodiments may be made without departing from the scope of the disclosure.

Claims

CLAIMSWhat is claimed is:

1. A device, comprising: a tube; a needle located partially within the tube, the needle including a sensor; and a sheath covering an interconnection of the needle and the tube.

2. The device of claim 1, further comprising a twisted pair of wires extending from the needle sensor.

3. The device of claim 2, wherein the twisted pair of wires are located within a channel of the needle.

4. The device of claim 1, wherein the sensor is a micro coil sensor located in a pocket of the needle.

5. The device of claim 1, wherein the sensor includes windings of wire wound around a portion of the needle.

6. The device of claim 1, wherein the sensor is a tunneling magnetoresistance sensor.

7. The device of claim 1, wherein the needle includes attachment features securing the needle to the tube.

8. The device of claim 7, wherein the attachment features include one or more of fins, machine marks, or a roughened surface.

9. The device of claim 1, wherein the tube comprises a polymeric material.

10. The device of claim 1, wherein the tube comprises two or more layers of polymeric material.

11. The device of claim 10, further comprising a twisted pair of wires extending from the sensor between two layers of polymeric material.

12. A system comprising: a catheter including a first sensor; a device configured for insertion through the catheter, the device including a second sensor; a tracking system configured to detect a location of the first sensor and the second sensor; and a memory storing an application, wherein execution of the application on a processor: displays a three-dimension (3D) model of a luminal network of a patient; displays, in the 3D model, a representation of a distal portion of the catheter at a detected position of the first sensor; displays, in the 3D model, a representation of the medical device at a detected position of the second sensor; and displays, in the 3D model, a target for placement of the medical device.

13. The system of claim 12, wherein the application when executed by the processor receives intra-procedural images and performs a local registration to update a relative position of the displayed representation of the distal portion of the catheter and the target in the 3D model.

14. The system of claim 12, wherein the medical device includes a needle connected to a distal portion of a tube, and wherein the second sensor is located in the needle.

15. The system of claim 14, further comprising a twisted pair of wires extending from the second sensor.

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