Medical device identification

Abstract

The present invention is entitled "Medical Device Identification". The present invention provides a medical device tracking system, in one embodiment, the medical device tracking system includes a medical device, the medical device including a handle and different interchangeable heads for insertion into the handle, the handle having a handle position tracking transducer disposed thereon, different corresponding heads in the interchangeable heads having corresponding head position tracking transducers disposed thereon and positioned differently so that when different corresponding heads in the heads are inserted into the handle, the different corresponding head position tracking transducers define different corresponding positions relative to the handle position tracking transducer; and a processing circuit for receiving signals generated by the handle position tracking transducer and the corresponding head position tracking transducers of the corresponding heads in the heads inserted into the handle, calculating the relative position between the handle position tracking transducer and the head position tracking transducer of the interchangeable heads that have been inserted into the handle, and identifying which interchangeable head is inserted into the handle in response to the calculated relative position.

Description

Technical Field

[0001] The present invention relates to medical devices and particularly, but not exclusively, to medical device identification. Background Art

[0002] Automatic identification of medical instruments is known in the art. For example, U.S. Patent 9,622,824 to Goldbach describes a method for identifying an instrument to be navigated using a medical navigation system, wherein the instrument includes a reference array having a plurality of markers forming a rigid body, and the positions of the markers relative to each other are not previously known in the navigation system as a characteristic arrangement of the specific instrument. The method includes measuring the distance of each marker relative to the other markers; identifying the spatial arrangement of the markers having the measured distances as an assignable marker array; assigning the assignable marker array to the instrument; and identifying the instrument based on the assigned marker array.

[0003] U.S. Patent 9,393,079 to Weese et al. describes a method and image processing system for evaluating projection images generated by an X-ray imaging system, wherein the images may show different instruments in a given set of interventional instruments (such as catheters or guidewires). The instruments are provided with markings such that their configuration is characteristic of the corresponding instrument. Preferably, three markings are arranged on a straight line, and the ratio of the distances between them is characteristic of the corresponding instrument. The image processing system can then identify the instrument present in a given projection and provide the user with functions corresponding to the instrument. In addition, if the marking configuration of the instrument is known a priori, the system can be used to locate the instrument of interest in the projection image.

[0004] US Patent Publication 2008 / 0200927 to Hartmann et al. describes a method and apparatus for identifying a component used in a navigation system. The navigation system may determine the identification of an instrument via an input. The input may be substantially automatic when the instrument is introduced into the field or assembly of the navigation system.

[0005] U.S. Patent 8,600,478 to Verard et al. describes a system and apparatus for determining identification and selected information associated with a surgical instrument in the vicinity of a reader. The information may be stored on a member operable to transmit the information to the reader at a selected time. The information may be used in a navigation system to aid in navigation of the instrument relative to the patient.

[0006] U.S. Patent Publication 2007 / 0080682 to Govari et al. describes a sensor assembly including a first magnetoresistive field sensor in a first surface mountable package that measures a first component and a second component of a magnetic field projected onto respective different first and second axes relative to a spatial orientation of the sensor, and generates a first orientation signal indicative of the measured first and second components. A second magnetoresistive field sensor in a second surface mountable package measures at least a third component of a magnetic field projected onto at least a third axis relative to the spatial orientation of the sensor, and generates a second orientation signal indicative of the measured third component. A substrate assembly orients the first field sensor in a first spatial orientation and orients the second field sensor in a second spatial orientation such that the third axis is oriented out of a plane containing the first and second axes. Summary of the invention

[0007] According to an embodiment of the present disclosure, a medical device tracking system is provided, which includes a medical device, which includes a handle and different rigid interchangeable heads for separate insertion into the handle, the handle having a handle position tracking transducer disposed thereon, different corresponding heads in the interchangeable heads having corresponding head position tracking transducers disposed thereon and positioned differently, so that when different corresponding heads in the interchangeable heads are inserted into the handle, the different corresponding head position tracking transducers define different corresponding positions relative to the handle position tracking transducer, and the processing circuit is configured to receive signals generated by the handle position tracking transducer and the corresponding head position tracking transducers of the corresponding heads in the interchangeable heads inserted into the handle, calculate the relative position between the handle position tracking transducer and the head position tracking transducer of the interchangeable heads inserted into the handle in response to the received signals, and identify which of the interchangeable heads is inserted into the handle in response to the calculated relative position.

[0008] Furthermore, according to embodiments of the present disclosure, the interchangeable heads differ from one another with respect to at least any one or more of the following: head shape or head size.

[0009] Also in accordance with an embodiment of the present disclosure, the processing circuit is configured to detect whether the inserted interchangeable head is properly inserted into the handle in response to the calculated relative orientation.

[0010] In addition, according to an embodiment of the present disclosure, the calculated relative orientation includes a calculated distance between a handle orientation tracking transducer and a head orientation tracking transducer that has been inserted into the interchangeable head, and the processing circuit is configured to identify which of the interchangeable heads is inserted into the handle in response to at least the calculated distance.

[0011] In addition, according to an embodiment of the present disclosure, the handle includes multiple rotational orientations for inserting different rigid interchangeable heads therein, the calculated relative orientation includes a calculated orientation of a head orientation tracking transducer of the inserted interchangeable head relative to a handle orientation tracking transducer, and the processing circuit is configured to identify which of the interchangeable heads is inserted into the handle in response to the calculated distance and the calculated orientation.

[0012] In addition, according to an embodiment of the present disclosure, the handle includes multiple rotational orientations to which different rigid interchangeable heads will be rotated, the calculated relative orientation includes a calculated orientation of a head orientation tracking transducer that has been inserted into the interchangeable head relative to a handle orientation tracking transducer, and the processing circuit is configured to identify which of the interchangeable heads is inserted into the handle in response to the calculated distance and the calculated orientation.

[0013] Also in accordance with an embodiment of the present disclosure, each of the interchangeable heads includes at least one cutting element.

[0014] In addition, according to an embodiment of the present disclosure, the medical device is configured for insertion into a body part of a living subject, the system also includes a positioning pad having at least one magnetic field radiator configured to transmit an alternating magnetic field to an area where the body part is located, and the head position tracking transducer of each of the interchangeable heads includes at least one coil configured to detect at least a portion of the transmitted alternating magnetic field.

[0015] Furthermore, according to an embodiment of the present disclosure, the head position tracking transducer of each of the interchangeable heads is a dual-axis transducer printed on a circuit board.

[0016] In addition, according to an embodiment of the present disclosure, the medical device is configured for insertion into a body part of a living subject, the system also includes a display, and the processing circuit is configured to track the position of the inserted interchangeable head in response to at least some of the received signals, and in response to the tracked position and the identified shape and size of the inserted interchangeable head, present an image including a representation of at least a portion of the body part and a representation of at least a portion of the inserted interchangeable head of the medical device in the body part to the display.

[0017] According to another embodiment of the present disclosure, a medical device tracking system is also provided, the system comprising a medical device, the medical device comprising a handle and different rigid interchangeable heads for separate insertion into the handle, the handle having a handle position tracking transducer disposed thereon, different corresponding heads in the interchangeable heads having corresponding head position tracking transducers disposed thereon and positioned differently, so that when different corresponding heads in the interchangeable heads are inserted into the handle, the different corresponding head position tracking transducers define different corresponding positions relative to the handle position tracking transducer, and the processing circuit is configured to Receive signals generated by a handle position tracking transducer and a corresponding head position tracking transducer of a corresponding head in an interchangeable head inserted into the handle, calculate a relative orientation between the handle position tracking transducer and the head position tracking transducer of the inserted interchangeable head in response to the received signals, receive a user identification of the inserted interchangeable head via a user input device, and associate the user identification of the inserted interchangeable head with the calculated relative orientation so as to allow subsequent identification of the inserted interchangeable head being reinserted into the handle in response to a new calculated relative orientation within a given tolerance of the calculated relative orientation.

[0018] Also in accordance with an embodiment of the present disclosure, the calculated relative orientation includes a calculated distance between a handle orientation tracking transducer and a head orientation tracking transducer of an inserted interchangeable head, and the processing circuit is configured to associate user identification of the inserted interchangeable head with the calculated distance so as to allow subsequent identification of the inserted interchangeable head being reinserted into the handle in response to at least a newly calculated distance within a given tolerance of the calculated distance.

[0019] In addition, according to an embodiment of the present disclosure, the handle includes multiple rotational orientations for inserting different rigid interchangeable heads therein, the calculated relative orientation includes a calculated orientation of a head orientation tracking transducer of the inserted interchangeable head relative to a handle orientation tracking transducer, and the processing circuit is configured to associate user identification of the inserted interchangeable head with the calculated distance and the calculated orientation so as to allow subsequent identification of the inserted interchangeable head being reinserted into the handle in response to a new calculated distance and a new calculated orientation that are within at least one given tolerance of the calculated distance and the calculated orientation, respectively.

[0020] In addition, according to an embodiment of the present disclosure, the handle includes multiple rotational orientations to which the different rigid interchangeable heads are to be rotated, the calculated relative orientation includes a calculated orientation of a head orientation tracking transducer of the inserted interchangeable head relative to a handle orientation tracking transducer, and the processing circuit is configured to associate user identification of the inserted interchangeable head with the calculated distance and the calculated orientation so as to allow subsequent identification of the inserted interchangeable head being reinserted into the handle in response to a new calculated distance and a new calculated orientation that are within at least one given tolerance of the calculated distance and the calculated orientation, respectively.

[0021] According to another embodiment of the present disclosure, a method for medical treatment using a medical device is also provided, the medical device comprising a handle and different rigid interchangeable heads for separate insertion into the handle, the handle having a handle position tracking transducer disposed thereon, and different corresponding heads in the interchangeable heads having corresponding head position tracking transducers disposed thereon and positioned differently, so that when different corresponding heads in the interchangeable heads are inserted into the handle, the different corresponding head position tracking transducers define different corresponding positions relative to the handle position tracking transducer, the method comprising receiving signals generated by the handle position tracking transducer and corresponding head position tracking transducers of corresponding heads in the interchangeable heads inserted into the handle, calculating the relative position between the handle position tracking transducer and the head position tracking transducer of the interchangeable heads inserted into the handle in response to the received signals, and identifying which of the interchangeable heads is inserted into the handle in response to the calculated relative position.

[0022] Furthermore, according to embodiments of the present disclosure, the interchangeable heads differ from one another with respect to at least any one or more of the following: head shape or head size.

[0023] Also in accordance with an embodiment of the present disclosure, the method includes detecting whether the inserted interchangeable head is properly inserted into the handle in response to the calculated relative orientation.

[0024] Additionally, according to an embodiment of the present disclosure, the calculated relative orientation includes a calculated distance between a handle orientation tracking transducer and a head orientation tracking transducer inserted into the interchangeable head, wherein identification includes identifying which of the interchangeable heads is inserted into the handle in response to at least the calculated distance.

[0025] In addition, according to an embodiment of the present disclosure, the handle includes multiple rotational orientations for inserting different rigid interchangeable heads therein, the calculated relative orientation includes a calculated orientation of a head orientation tracking transducer of the inserted interchangeable head relative to a handle orientation tracking transducer, and the identification includes identifying which of the interchangeable heads is inserted into the handle in response to the calculated distance and the calculated orientation.

[0026] In addition, according to an embodiment of the present disclosure, the handle includes multiple rotational orientations to which different rigid interchangeable heads will be rotated, the calculated relative orientation includes a calculated orientation of a head orientation tracking transducer that has been inserted into the interchangeable heads relative to a handle orientation tracking transducer, and the identification includes identifying which of the interchangeable heads is inserted into the handle in response to the calculated distance and the calculated orientation.

[0027] Also in accordance with an embodiment of the present disclosure, each of the interchangeable heads includes at least one cutting element.

[0028] In addition, according to an embodiment of the present disclosure, the medical device is configured for insertion into a body part of a living subject, the method also includes transmitting an alternating magnetic field into an area where the body part is located, the head position tracking transducer of each interchangeable head includes at least one coil, and at least a portion of the transmitted alternating magnetic field is detected by the at least one coil.

[0029] Furthermore, according to an embodiment of the present disclosure, the head position tracking transducer of each of the interchangeable heads is a dual-axis transducer printed on a circuit board.

[0030] In addition, according to an embodiment of the present disclosure, the medical device is configured for insertion into a body part of a living subject, and the method also includes tracking the position of the inserted interchangeable head in response to at least some of the received signals, and in response to the tracked position and the identified shape and size of the inserted interchangeable head, presenting to a display an image including a representation of at least a portion of the body part and a representation of at least a portion of the inserted interchangeable head of the medical device in the body part. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] The present invention will be understood from the following detailed description in conjunction with the accompanying drawings, in which:

[0032] Figure 1 is a schematic diagram of a medical procedure system according to an embodiment of the present invention;

[0033] Figure 2 A schematic diagram of a magnetic field radiation component used in a medical procedure system according to an embodiment of the present invention;

[0034] Figure 3 For use Figure 1 A schematic diagram of a medical device in a system;

[0035] Figure 4 Shows Figure 3 Handles and interchangeable heads of medical devices;

[0036] Figure 5 Shows the settings Figure 3 A transducer on a handle and an interchangeable head of a medical device;

[0037] Figure 6 To include Figure 5 A flowchart of exemplary steps in a method for calibrating a medical device;

[0038] Figure 7 To include Figure 1 A flowchart of exemplary steps in a method of operating a medical procedure system; and

[0039] Figure 8 for Figure 1 A schematic diagram of a medical procedure system presenting an image of a body part and a representation of an interchangeable head into which has been inserted. DETAILED DESCRIPTION

[0040] Overview

[0041] Some medical devices may include a handle with multiple interchangeable rigid heads. Different interchangeable rigid heads may have different sizes and / or shapes to perform different functions and / or access different body parts. In one such example, the rigid head may include at least one cutting element at its distal end, such as a rotating blade and / or rotating burr, to remove tissue within a body part of a living subject. Some of the rigid heads may be generally straight, while others may include curved portions.

[0042] Some medical devices may allow the head to be inserted into the handle in one of a plurality of rotational orientations. In addition or alternatively, some medical devices may allow the inserted head to be rotated to a plurality of rotational orientations. In this case, it may be challenging for the physician to accurately navigate the head of the medical device (including roll information) in the body part. Using an orientation tracking sensor on the distal end of the handle of the medical device may not provide useful information about the rotational orientation of the head. In addition, there may be a significant distance from the handle to the distal end of the head, and angular orientation errors exacerbate distance errors. In addition, when the head is a metal head, metal interference from the head may further distort the reading. It may also be challenging to place large and complex sensors and controllers (such as EEPROM) on the head because of the lack of space for controller components and cables.

[0043] Additionally, even if the rotational orientation of the head is not a factor, navigation may require knowing which of the heads is currently inserted into the medical device. The physician may manually record which head is being used with the navigation system. However, during a medical procedure, the head may be replaced multiple times, and manually recording which head is being used with the navigation system takes time and is prone to error.

[0044] Embodiments of the present invention include medical devices having a handle and interchangeable heads of different rigidity for separate insertion into the handle. The interchangeable heads may differ from each other by way of example only with respect to shape and / or head size and / or function. In some embodiments, at least some of the heads may include at least one cutting element by way of example only.

[0045] The handle has a handle position tracking transducer disposed thereon. Each of the interchangeable heads has a head position tracking transducer disposed thereon. The head position tracking transducers are strategically placed on the interchangeable heads so that when each interchangeable head is individually inserted into the handle, the relative position of the head position tracking transducer to the head position tracking transducer of the inserted interchangeable head uniquely identifies the inserted interchangeable head, regardless of the rotational orientation in which the interchangeable head is inserted into the handle and regardless of the rotational orientation to which the inserted interchangeable head is rotated.

[0046] Thus, different respective ones of the interchangeable heads have differently positioned respective head position tracking transducers disposed thereon, such that when different respective ones of the interchangeable heads are inserted into the handle, the different respective head position tracking transducers define different respective positions relative to the handle position tracking transducer. In other words, when one head is inserted into the handle, the head is associated with a certain relative position (or positions) between its head position tracking transducer and the handle position tracking transducer, and when another head is inserted into the handle, the other head is associated with a different relative position (or positions) between its head position tracking transducer and the handle position tracking transducer.

[0047] Different relative positions of different heads can be calculated in the calibration phase. The calculated relative positions can then be linked to the associated heads in a lookup table or the like for subsequent lookup. In this way, different relative positions can then be used to identify which head is inserted into the handle, as described in detail below.

[0048] Each head position tracking transducer may be a dual-axis transducer (e.g., comprising two orthogonal wound coils) that can track the position and orientation (including roll) of the corresponding head. The dual-axis transducer may be printed on a printed circuit board (PCB) for attachment to the head. In some embodiments where the head is fixed relative to the handle, a single-axis transducer may be used. In some embodiments, the handle position tracking transducer may be a dual-axis or tri-axis transducer by way of example only.

[0049] There are several advantages to using a PCB transducer. First, a PCB transducer is not interfered by metal. Second, the PCB can be placed very accurately on the head. Third, the PCB transducer is not a wound coil, but a standard printed coil, so that each PCB has essentially the same magnetic sensitivity. Therefore, based on the above advantages, a PCB transducer generally does not require calibration, and therefore does not require a controller (e.g., an EEPROM) that is generally too large to be placed on the head.

[0050] The processing circuit receives signals generated by the handle position tracking transducer and the head position tracking transducer of the interchangeable head inserted into the handle. The processing circuit calculates the relative position (which may include distance and / or orientation) between the handle position tracking transducer and the head position tracking transducer of the inserted interchangeable head in response to the received signals. The processing circuit then identifies which of the interchangeable heads is inserted into the handle in response to the calculated relative position and the data calculated during the calibration phase. The calculated relative position can also be used to detect whether the inserted interchangeable head is correctly inserted into the handle based on whether the calculated relative position is sufficiently correlated with one of the calculated relative positions in the calibration data.

[0051] The position of the inserted interchangeable head may be tracked in response to at least some of the signals received from the handle position tracking transducer and / or the head position tracking transducer of the inserted head. In response to the tracked position and the identified shape and size of the inserted interchangeable head, an image including a representation of at least a portion of the body part and a representation of at least a portion of the inserted interchangeable head of the medical device in the body part may be presented to a display.

[0052] System Description

[0053] Documents incorporated herein by reference are to be considered an integral part of this application, except that, to the extent any term is defined in these incorporated documents in a manner that contradicts a definition explicitly or implicitly made in this specification, only the definition in this specification shall prevail.

[0054] Turning now to the drawings, according to an embodiment of the present invention, reference is now made to Figure 1 , which is a schematic diagram of a medical procedure system 20, and reference Figure 2 , which is a schematic diagram of a magnetic field radiating component positioning pad 24 used in system 20. Medical procedure system 20 is typically used during an invasive and / or exploratory procedure on a patient 22's sinuses or another body part, such as the brain.

[0055] For this procedure, the component 24 can be positioned behind and / or around the head of the patient 22, for example, by fixing the magnetic field radiation component 24 to a chair 25 (or bed) on which the patient sits (or lies). The magnetic field radiation component 24 in the illustrated example includes five magnetic field radiators 26 fixed in a horseshoe-shaped frame, which is positioned under or around the patient 22 so that the magnetic field radiators 26 surround the head of the patient 22. Alternatively, a smaller or larger number of radiators 26 in various configurations can be used. The magnetic field radiator 26 is configured to radiate an alternating magnetic field at a corresponding frequency into an area 30 where a body part is located, which is adjacent to the magnetic field radiation component 24 and includes the head of the patient 22.

[0056] The alternating magnetic field induces signals in the position tracking transducer 32 and the position tracking transducer 36. The position tracking transducer 32 is shown to be disposed on the medical device 28 so as to track the position of the medical device 28. The position tracking transducer 36 is shown to be disposed on the patient 22 (e.g., on the forehead of the patient 22 or any other suitable body part) so as to track the position of the patient 22 (e.g., to track the position of the head of the patient 22), thereby compensating for the movement of the patient relative to the magnetic field radiating assembly 24. By way of example only, the medical device 28 may include any one or more of the following: a probe for insertion into a body part, an endoscope, and / or a surgical tool (such as an ENT tool, a suction tool, a minimally invasive instrument, or a razor).

[0057] The position of the distal end of the medical device 28 and the position of the patient 22 may be tracked using a tracking subsystem that tracks the position and orientation coordinates of a position tracking transducer 32 and a position tracking transducer 36 mounted at the distal end, respectively. The position tracking transducers 32, 36 are configured to output signals indicative of the positions of the transducers 32, 36, respectively. The signals are processed by the tracking subsystem running on processing circuitry 38 to track the position of the distal end of the medical device 28 and the position of the patient 22 over time. In an embodiment in which the tracking subsystem is a magnetic tracking subsystem, the position tracking transducer 32 and / or the position tracking transducer 36 include at least one coil that is referenced to the position of the distal end of the medical device 28. Figure 5 In other embodiments, the tracking subsystem can be an electrical-based tracking subsystem that uses multiple head surface electrodes (e.g., multiple instances of the position tracking transducer 36) to track the position of the medical device 28 based on signals emitted by at least one electrode of the medical device 28 (included in the position tracking transducer 32). The tracking subsystem can be implemented using any suitable position tracking subsystem, such as, but not limited to, an ultrasound-based tracking system, wherein the position tracking transducer 32 includes at least one ultrasound transducer. Using the tracking subsystem, the physician 54 advances the distal end of the medical device 28 into the body part, as described in detail below.

[0058] In some embodiments, the medical device 28 is attached to and held by a robotic arm 40 that is configured to manipulate the medical device 28. The robotic arm 40 includes a plurality of robotic joints configured to control movement of the robotic arm 40 and manipulate the medical device 28. In other embodiments, the medical device 28 is held and manipulated by a physician 54.

[0059] As described in detail below, the position tracking transducer 32 is attached to the medical device 28, and determination of the position and orientation of the position tracking transducer 32 enables tracking of the position and orientation of the distal end 34 (or other location) of the medical device 28, which can be reversibly inserted into a body part of a patient 22 (a living subject).

[0060] Similarly, determination of the position and orientation of position tracking transducer 36 enables tracking of the position and orientation of a portion (e.g., the head) of patient 22. Position tracking transducer 36 is Figure 1 2 is shown as being disposed on the forehead of the patient 22. The position tracking transducer 36 may be disposed on any other suitable body part of the patient 22 to track the position / movement of the patient 22.

[0061] Systems for tracking an object inserted into a patient using a magnetic field radiator, such as magnetic field radiator 26, are described in U.S. Patent Publication No. 2016 / 0007842 to Govari et al., which is incorporated herein by reference. In addition, a magnetic field radiator manufactured by Biosense Webster (33 Technology Drive, Irvine, CA 92618 USA) is described in U.S. Patent Publication No. 2016 / 0007842 to Govari et al., which is incorporated herein by reference. The system uses a tracking system similar to that described herein to find the position and orientation of the coil in an area irradiated by a magnetic field.

[0062] The robotic arm 40 typically has its own robotic coordinate system. The robotic coordinate system is aligned with the magnetic coordinate system of the magnetic field radiator 26, or vice versa. Alignment of the robotic coordinate system with the magnetic coordinate system can be performed, for example, by moving the robotic arm 40 or a medical device 28 attached to the robotic arm 40 to one or more known positions of the magnetic field radiator 26, such as to a position on the magnetic field radiating assembly 24 or to the position tracking transducer 36 or to one or more other known positions on the patient 22. Once alignment of the robotic coordinate system with the magnetic coordinate system has been performed, the position in the magnetic coordinate system can be translated to the robotic coordinate system in order to properly manipulate the robotic arm 40.

[0063] The elements of the system 20, including the radiator 26, can be controlled by a processing circuit 38, which includes a processing unit that communicates with one or more memories. Typically, the elements can be connected to the processing circuit 38 via a cable, for example, the radiator 26 can be connected to the processing circuit 38 via a cable 58. Alternatively or in addition, the elements can be wirelessly connected to the processing circuit 38. The processing circuit 38 can be installed in a console 50, which includes an operating control 51, which typically includes a keypad and / or a pointing device such as a mouse or trackball. The console 50 is also connected to other elements of the medical procedure system 20, such as the proximal end 52 of the medical device 28. The physician 54 interacts with the processing circuit 38 using the operating control 51 while performing the procedure, and the processing circuit 38 can present the results generated by the system 20 on a display 56.

[0064] In some embodiments, prior to performing a medical procedure, a CT image of patient 22 is acquired. The CT image is stored in a memory (not shown) for subsequent retrieval by processing circuitry 38. Figure 1 , the display 56 is shown displaying various views 59 of a previous CT scan (or other suitable scan) which can be used as an aid to the physician 54 in guiding the medical device 28 in the body part. The display screen 56 also shows an image 61 captured by a camera (not shown) of the medical device 28. The CT image can be registered with the magnetic coordinate system so that a representation of the medical device 28 can be displayed on the display 56 along with the CT image, which will be described in conjunction with Figure 7 and Figure 8 Describe in detail.

[0065] In the implementation process, some or all of these functions of the processing circuit 38 can be combined in a single physical component, or alternatively, multiple physical components are used to implement. These physical components may include hard-wired or programmable devices, or a combination of the two. In some embodiments, at least some of the functions of the processing circuit can be implemented by a programmable processor under the control of suitable software. The software can be downloaded to the device in electronic form via (for example) a network. Alternatively or in addition to this, the software can be stored in a tangible non-transient computer-readable storage medium, such as an optical, magnetic or electronic memory.

[0066] See now Figure 3 , which is used for Figure 1 Schematic diagram of a medical device 28 in a system 20. The medical device 28 includes a handle 62 into which a plurality of different rigid interchangeable heads 64 are individually and reversibly insertable. Figure 3 One of the interchangeable heads 64 is shown inserted into the handle 62. The other of the interchangeable heads 64 is shown in FIG. Figure 4 as described below. Figure 3 The illustrated medical device 28 also includes an irrigation or drainage tube 66 .

[0067] Figure 3 The illustrated medical device 28 is shown before any position tracking transducers are added to the medical device 28. In fact, in some embodiments, the medical device 28 can be implemented using commercially available off-the-shelf medical devices that do not have position tracking transducers or sensors and adding position tracking transducers at appropriate locations, which will be referenced below. Figure 5 Description. For example, Bien The S120 handpiece and interchangeable reusable blades (available in a form without a position tracking transducer) can be adapted to provide the medical device 28 described below. In other embodiments, the medical device 28 can be implemented as a purpose-built medical device with an integral position tracking transducer.

[0068] Reference now Figure 4 , which shows Figure 3 The medical device 28 includes a handle 62 and a plurality of different interchangeable heads 64 . Figure 4 The illustrated handle 62 and interchangeable heads 64 are also shown without the position tracking transducer.The interchangeable heads 64 differ from one another with respect to head shape and / or head size.

[0069] Each interchangeable head 64 includes a plastic proximal end 68 that is inserted into a socket 70 of the handle 62. The socket 70 of the handle 62 includes multiple rotational orientations in which to insert different rigid interchangeable heads 64. For example, using the S120 handpiece, the reusable blade can be inserted into eight different rotational orientations. In some embodiments, the interchangeable head 64 can be inserted into the socket 70 in a single rotational orientation.

[0070] The handle 62 includes a plurality of rotational orientations into which the different rigid interchangeable heads 64 will rotate. Thus, once one of the interchangeable heads 64 is inserted into the socket 70, the inserted interchangeable head 64 can be rotated into a plurality of rotational orientations using the rotation adjustment gear 72. In other embodiments, the inserted interchangeable head 64 cannot be rotated into another orientation.

[0071] exist Figure 4 In the example of FIG. 5 , each of the interchangeable heads 64 is implemented with an elongated shaft 74 having a distal end 76, the interchangeable head including at least one cutting element 78 disposed at the distal end 76 of the elongated shaft 74. The cutting element 78 may include a shaving bar (e.g., a rough surface cylindrical or spherical element) or a shaving blade that rotates within the elongated shaft 74 or any other suitable cutting element.

[0072] Reference now Figure 5 , which shows the setting Figure 3 The medical device 28 of the present invention is provided with transducers 80, 82 on the handle 62 and the interchangeable head 64. The handle 62 has a handle position tracking transducer 80 disposed thereon. The handle position tracking transducer 80 may include a dual-axis or tri-axis transducer, which may be used to detect the position and orientation (including roll) of the handle 62. In some embodiments, the handle position tracking transducer 80 may include at least one coil, such as two or three orthogonally placed coils.

[0073] Each interchangeable head 64 includes a head position tracking transducer 82 disposed thereon, located at the distal end 76 of the elongated shaft 74 of the interchangeable head 64. The head position tracking transducer 82 is electrically insulated from the elongated shaft 74 and the cutting element 78. A wire extending from the head position tracking transducer 82 is secured to the elongated shaft 74 using, for example, a self-adhesive tape 75.

[0074] In some embodiments, the head position tracking transducer 82 of each interchangeable head 64 may include at least one coil. The head position tracking transducer 82 of each interchangeable head 64 may include a dual-axis transducer (e.g., including two orthogonally placed coils) that can be used to detect the position and orientation (including roll) of the interchangeable head 64. The head position tracking transducer 82 may be printed on one or two printed circuit boards. For example, two coils may be printed on one or two printed circuit boards that are connected to the distal end 76 of the elongated shaft 74 so that each of the coils is orthogonal to each other. Printing the coils on a printed circuit board provides a more compact and more standard transducer than using a wound coil. The coils may be coated with an electrically insulating material.

[0075] The handle position tracking transducer 80 and the head position tracking transducer 82 of each interchangeable head 64 are configured to detect at least a portion of the alternating magnetic field transmitted by the magnetic field radiator 26 ( Figure 2 ).

[0076] Prior to inserting the elongated shaft 74 into the body part, at least some of the elongated shaft 74 may be disposed in a plastic biocompatible sleeve. In some embodiments, the sleeve may cover the elongated shaft 74 from the plastic proximal end 68 up to and including the head position tracking transducer 82.

[0077] The head position tracking transducers 82 are strategically placed on the interchangeable heads 64 so that when each interchangeable head 64 is individually inserted into the handle 62, the relative position between the handle position tracking transducer 80 and the head position tracking transducer 82 of the inserted interchangeable head 64 uniquely identifies the inserted interchangeable head 64, regardless of the rotational orientation in which the interchangeable head 64 is inserted into the handle 62 and regardless of the rotational orientation to which the inserted interchangeable head 64 is rotated. The relative position may include: (i) a distance D between the handle position tracking transducer 80 and one of the head position tracking transducers 82; and / or (ii) a relative orientation (which may or may not include roll) between the handle position tracking transducer 80 and one of the head position tracking transducers 82.

[0078] Therefore, different corresponding heads among the interchangeable heads 64 have corresponding head position tracking transducers 82 positioned differently thereon (on the distal end 76 of the corresponding head 64) so ​​that when different corresponding heads among the interchangeable heads 64 are inserted into the handle 62, the different corresponding head position tracking transducers 82 define different corresponding positions relative to the handle position tracking transducer 80.

[0079] Reference now Figure 6 , which includes Figure 5 90 of exemplary steps in a method of calibrating a medical device 28. See also Figure 5 One of the interchangeable heads 64 is inserted (block 92) into the handle 62. The processing circuit 38 is configured to operate the control 51 ( Figure 1 )) Receive (box 94) the user identification that has been inserted into the interchangeable head 64.

[0080] Processing circuit 38 ( Figure 1 ) is configured to receive (block 96) signals generated by the handle position tracking transducer 80 and signals generated by the corresponding head position tracking transducer 82 of the corresponding head in the interchangeable head 64 inserted into the handle 62. The processing circuit 38 is configured to calculate (block 98) the relative position between the handle position tracking transducer 80 and the head position tracking transducer 82 inserted into the interchangeable head 64 in response to the received signals. The calculated relative position may include: (i) a calculated distance D between the handle position tracking transducer 80 and the head position tracking transducer 82 inserted into the interchangeable head 64; and / or (ii) a calculated relative orientation (which may or may not include roll) between the handle position tracking transducer 80 and the head position tracking transducer 82 inserted into the interchangeable head 64.

[0081] The processing circuit 38 is configured to associate the user identification of the inserted interchangeable head 64 with the calculated relative position (e.g., calculated distance and / or calculated relative orientation) (block 100) to allow subsequent identification of the inserted interchangeable head 64 being reinserted into the handle in response to a new calculated relative position (e.g., new calculated distance and / or new calculated relative orientation) within a given tolerance of the calculated relative position (e.g., calculated distance and / or calculated relative orientation). The given tolerance may be any suitable value, for example, the given tolerance may be in the range of 0.1 mm to 5 mm and / or an angular orientation tolerance of up to 5 or 10%.

[0082] At decision block 102, the processing circuit 38 presents a question to the display 56 asking the user whether there is another rotational orientation in which to insert the interchangeable head 64 or to rotate the inserted interchangeable head 64 to the rotational orientation. The user provides a response via the operating control 51 for the processing circuit 38 to receive. If the user responds that there is another rotational orientation (branch 104), the user rotates (block 106) the inserted interchangeable head 64 to the new rotational orientation, and the method continues with the steps of block 96. When the inserted interchangeable head 64 is freely rotatable relative to the handle 62, the user may indicate this to the response to the presented question at the step of block 102, and then continuously rotate the inserted interchangeable head 64 while repeating the steps of blocks 96 to 100 for different rotational orientations of the inserted interchangeable head 64. If the user responds that there are no more rotational orientations (branch 108), the processing circuit 38 presents (block 110) a question to the display 56 asking the user whether there are more interchangeable heads 64 to be corrected. The user responds to this question. If there are more interchangeable heads 64 to be calibrated (branch 112), the current head is removed (box 114), and the new interchangeable head 64 is inserted in the step of box 92, and then the steps in the process 90 are followed as described above. If there are no more interchangeable heads 64 to be calibrated (branch 116), the method ends (box 118).

[0083] The above-described calibration method may include an additional step to check whether the calculated relative position between the handle position tracking transducer 80 and the head position tracking transducer 82 that has been inserted into the interchangeable head 64 is the same as or within a given tolerance as the previously calculated relative position between the handle position tracking transducer 80 and the head position tracking transducer 82 of another of the interchangeable heads 64. If the calculated relative position is the same as or within a given tolerance as the previously calculated relative position between the handle position tracking transducer 80 and the head position tracking transducer 82 of another of the interchangeable heads 64, the processing circuit 38 may present a message to the display 56, thereby notifying the user that the current placement of the head position tracking transducer 82 should be changed.

[0084] The correction data is saved in a table for later use during operation of the system 20 and will be referenced Figure 7 Described below.

[0085] See now Figure 7 , which includes Figure 1 120 of exemplary steps in a method of operating a medical procedure system 20. Figure 5 The physician 54 inserts (block 122) one of the interchangeable heads 64 into the handle 62. The processing circuit 38 ( Figure 1) is configured to receive (block 124) signals generated by the handle position tracking transducer 80 and signals generated by the corresponding head position tracking transducer 82 of the corresponding head of the interchangeable heads 64 inserted into the handle. The processing circuit 38 is configured to calculate (block 126) the relative position (e.g., distance and / or orientation) between the handle position tracking transducer 80 and the head position tracking transducer 82 inserted into the interchangeable heads 64 in response to the received signals. The processing circuit 38 is configured (block 128) to identify which of the interchangeable heads 64 is inserted into the handle in response to the calculated relative position (e.g., distance and / or orientation), and optionally to identify whether the interchangeable heads 64 are correctly inserted into the handle 62 in response to the calculated relative position. The steps of block 128 include the sub-steps described below.

[0086] The processing circuit 38 is configured to compare the calculated relative orientation with the values ​​in the stored table of relative orientations and associated interchangeable heads 64 (block 130). At decision block 132, the processing circuit 38 determines whether the table includes a value within a given tolerance of the calculated relative orientation. If no value in the table is within a given tolerance of the calculated relative orientation (branch 134), the processing circuit 38 may present (block 136) a message to the display 56 indicating that the interchangeable head 64 was not identified or was not correctly inserted into the handle 62. The process then continues with the steps of block 122.

[0087] If there is a value in the table that is within a given tolerance of the calculated relative orientation (branch 138 ), the interchangeable head 64 is identified (box 140 ) as the interchangeable head 64 associated with the value in the table, and the inserted interchangeable head 64 is identified as being correctly inserted into the handle 62 .

[0088] The processing circuit 38 is configured to track (block 142) the position of the inserted interchangeable head 64 in response to at least some of the received signals. The signals used to track the position of the inserted interchangeable head 64 may be based on signals received from the handle position tracking transducer 80 and / or signals received from the head position tracking transducer 82 into which the interchangeable head 64 has been inserted. When the interchangeable head 64 may be, for example, using the gear 72 ( Figure 4 ) is freely rotated, typically tracking the position of the inserted interchangeable head 64 based at least on signals received from the head orientation tracking transducer 82 of the inserted head 64.

[0089] See now Figure 8 , the reason for which Figure 1 A schematic diagram of a medical procedure system 20 presenting a representation 148 of a body part and an image 146 of a representation 150 of an inserted interchangeable head 64. Also refer to Figure 5 and Figure 7In response to the tracked position and the identified shape and size of the inserted interchangeable head 64, the processing circuit 38 is configured to display to the display 56 ( Figure 1 ) presents (block 144) an image 146 that includes a representation 148 of at least a portion of a body part and a representation 150 of at least a portion of the inserted interchangeable head 64 of the medical device 28 in the body part. Because the interchangeable head 64 is rigid, the representation 150 of the inserted interchangeable head 64 can be presented based on the orientation of a single point of the inserted interchangeable head 64 and the known shape and size of the identified inserted interchangeable head 64. An indicator 152 on the representation 150 can also be used to indicate the cutting element 78.

[0090] For the sake of clarity, various features of the present invention described in the context of independent embodiments may also be provided in combination in a single embodiment. Conversely, for the sake of simplicity, various features of the present invention described in the context of a single embodiment may also be provided individually or in any suitable sub-combination.

[0091] The above embodiments are cited by way of example, and the present invention is not limited by what is specifically shown and described above. On the contrary, the scope of the present invention includes combinations and sub-combinations of the various features described above, as well as variations and modifications thereof, which should occur to those skilled in the art when reading the above description, and which are not disclosed in the prior art.

Claims

1. A medical device tracking system, comprising: A medical device comprising a handle and different rigid interchangeable heads for separate insertion into the handle, the handle having a handle position tracking transducer disposed thereon, different corresponding heads of the interchangeable heads having differently positioned corresponding head position tracking transducers disposed thereon such that when different corresponding heads of the interchangeable heads are inserted into the handle, the different corresponding head position tracking transducers define different corresponding positions relative to the handle position tracking transducer; and A processing circuit, the processing circuit being configured to: receiving signals generated by the handle position tracking transducer and a corresponding head position tracking transducer of a corresponding one of the interchangeable heads inserted into the handle; calculating a relative position between the handle position tracking transducer and the head position tracking transducer of the inserted interchangeable head in response to the received signal; as well as Which of the interchangeable heads is inserted into the handle is identified responsive to the calculated relative orientation.

2. The system of claim 1, wherein the interchangeable heads differ from one another with respect to at least one or more of: head shape; or head size.

3. The system of claim 1, wherein the processing circuit is configured to detect whether the inserted interchangeable head is properly inserted into the handle in response to the calculated relative orientation.

4. A system according to claim 1, wherein the calculated relative orientation includes a calculated distance between the handle orientation tracking transducer and the head orientation tracking transducer of the inserted interchangeable head, and the processing circuit is configured to identify which of the interchangeable heads is inserted into the handle at least in response to the calculated distance.

5. A system according to claim 4, wherein the handle includes multiple rotational orientations in which the different rigid interchangeable heads can be inserted, the calculated relative orientation includes a calculated orientation of the head orientation tracking transducer of the inserted interchangeable head relative to the handle orientation tracking transducer, and the processing circuit is configured to identify which of the interchangeable heads is inserted into the handle in response to the calculated distance and the calculated orientation.

6. A system according to claim 4, wherein the handle includes multiple rotational orientations, the different rigid interchangeable heads can be rotated to the multiple rotational orientations, the calculated relative orientation includes a calculated orientation of the head orientation tracking transducer of the inserted interchangeable head relative to the handle orientation tracking transducer, and the processing circuit is configured to identify which of the interchangeable heads is inserted into the handle in response to the calculated distance and the calculated orientation.

7. The system of claim 1, wherein each of the interchangeable heads comprises at least one cutting element.

8. A system according to claim 1, wherein the medical device is configured for insertion into a body part of a living subject, the system also comprising a positioning pad having at least one magnetic field radiator configured to transmit an alternating magnetic field to an area where the body part is located, the head position tracking transducer of each of the interchangeable heads comprising at least one coil configured to detect at least a portion of the transmitted alternating magnetic field.

9. The system of claim 8, wherein the head position tracking transducer of each of the interchangeable heads is a dual-axis transducer printed on a circuit board.

10. The system of claim 1, wherein the medical device is configured for insertion into a body part of a living subject, the system further comprising a display, the processing circuit being configured to: tracking a position of the inserted interchangeable head in response to at least some of the received signals; and In response to the tracked position and the identified shape and size of the inserted interchangeable head, an image including a representation of at least a portion of the body part and a representation of at least a portion of the inserted interchangeable head of the medical device in the body part is presented to the display.

11. A medical device tracking system comprising: A medical device comprising a handle and different rigid interchangeable heads for separate insertion into the handle, the handle having a handle position tracking transducer disposed thereon, different corresponding heads of the interchangeable heads having differently positioned corresponding head position tracking transducers disposed thereon such that when different corresponding heads of the interchangeable heads are inserted into the handle, the different corresponding head position tracking transducers define different corresponding positions relative to the handle position tracking transducer; and A processing circuit, the processing circuit being configured to: receiving signals generated by the handle position tracking transducer and a corresponding head position tracking transducer of a corresponding one of the interchangeable heads inserted into the handle; calculating a relative position between the handle position tracking transducer and the head position tracking transducer of the inserted interchangeable head in response to the received signal; receiving, via a user input device, a user identification of the interchangeable head that has been inserted; as well as The user identification of the inserted interchangeable head is associated with the calculated relative orientation to allow subsequent identification of the inserted interchangeable head to be reinserted into the handle in response to a new calculated relative orientation within a given tolerance of the calculated relative orientation.

12. A system according to claim 11, wherein the calculated relative orientation includes a calculated distance between the handle orientation tracking transducer and the head orientation tracking transducer of the inserted interchangeable head, and the processing circuit is configured to associate the user identification of the inserted interchangeable head with the calculated distance so as to allow subsequent identification of the inserted interchangeable head being reinserted into the handle at least in response to a new calculated distance within a given tolerance of the calculated distance.

13. A system according to claim 12, wherein the handle includes multiple rotational orientations in which the different rigid interchangeable heads can be inserted, the calculated relative orientation includes a calculated orientation of the head orientation tracking transducer of the inserted interchangeable head relative to the handle orientation tracking transducer, and the processing circuit is configured to associate the user identification of the inserted interchangeable head with the calculated distance and the calculated orientation so as to allow subsequent identification of the inserted interchangeable head to be reinserted into the handle in response to a new calculated distance and a new calculated orientation that are within at least one given tolerance of the calculated distance and the calculated orientation, respectively.

14. A system according to claim 12, wherein the handle includes multiple rotational orientations, the different rigid interchangeable heads can be rotated to the multiple rotational orientations, the calculated relative orientation includes a calculated orientation of the head orientation tracking transducer of the inserted interchangeable head relative to the handle orientation tracking transducer, and the processing circuit is configured to associate the user identification of the inserted interchangeable head with the calculated distance and the calculated orientation so as to allow subsequent identification of the inserted interchangeable head to be reinserted into the handle in response to a new calculated distance and a new calculated orientation that are within at least one given tolerance of the calculated distance and the calculated orientation, respectively.

15. A method for identifying a medical device, the medical device comprising a handle and different rigid interchangeable heads for separate insertion into the handle, the handle having a handle position tracking transducer disposed thereon, different corresponding heads of the interchangeable heads having differently positioned corresponding head position tracking transducers disposed thereon, such that when different corresponding heads of the interchangeable heads are inserted into the handle, different corresponding head position tracking transducers define different corresponding positions relative to the handle position tracking transducer, the method comprising; receiving signals generated by the handle position tracking transducer and a corresponding head position tracking transducer of a corresponding one of the interchangeable heads inserted into the handle; calculating a relative position between the handle position tracking transducer and the head position tracking transducer of the inserted interchangeable head in response to the received signal; as well as Which of the interchangeable heads is inserted into the handle is identified responsive to the calculated relative orientation.

16. The method of claim 15, wherein the interchangeable heads differ from one another with respect to at least one or more of: head shape; or head size.

17. The method of claim 15, further comprising detecting whether the inserted interchangeable head is properly inserted into the handle in response to the calculated relative orientation.

18. A method according to claim 15, wherein the calculated relative orientation includes a calculated distance between the handle orientation tracking transducer and the head orientation tracking transducer of the inserted interchangeable heads, and wherein identifying which of the interchangeable heads is inserted into the handle in response to the calculated relative orientation includes identifying which of the interchangeable heads is inserted into the handle in response to at least the calculated distance.

19. A method according to claim 18, wherein the handle includes multiple rotational orientations, and the different rigid interchangeable heads can be inserted into the multiple rotational orientations, the calculated relative orientation includes a calculated orientation of the head orientation tracking transducer of the inserted interchangeable head relative to the handle orientation tracking transducer, and the identifying which of the interchangeable heads is inserted into the handle in response to the calculated relative orientation includes identifying which of the interchangeable heads is inserted into the handle in response to the calculated distance and the calculated orientation.

20. A method according to claim 18, wherein the handle includes multiple rotational orientations, the different rigid interchangeable heads can be rotated to the multiple rotational orientations, the calculated relative orientation includes a calculated orientation of the head orientation tracking transducer of the inserted interchangeable head relative to the handle orientation tracking transducer, and the identifying which of the interchangeable heads is inserted into the handle in response to the calculated relative orientation includes identifying which of the interchangeable heads is inserted into the handle in response to the calculated distance and the calculated orientation.

21. The method of claim 15, wherein each of the interchangeable heads comprises at least one cutting element.

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