Kit of surgical instruments for facilitating a combined use of taking a brain biopsy from a patient's brain and of inserting an anchor bolt into a patient's skull

Abstract

Disclosed is a kit of surgical instruments for facilitating a combined use of taking a brain biopsy from a patient's brain and of inserting an anchor bolt into a patient's skull is presented. The kit comprises a tracking array, an alignment reduction tube, and an alignment guide tube. The presented kit of surgical instruments can be beneficially used for the combined navigated and robotic and / or computer-assisted biopsy and placement of an anchor bolt in a patient's skull. In this regard, one core idea for this kit is that the diameters of the bone anchor and the tubes are matched to each other, enabling the goal of combining the procedure of taking a brain biopsy with e.g. a LITT procedure. The tracking array is configured to be tracked by a tracking system, and the tracking array comprises a guide tube configured for receiving the alignment reduction tube, wherein the alignment reduction tube is configured for receiving the alignment guide tube. The alignment guide tube is configured for receiving a system for taking a brain biopsy from the patient's brain, and wherein the alignment reduction tube is configured for receiving an anchor bolt for being inserted into the patient's skull.

Description

[0001] Brainlab AG

[0002] Attorney’s File: B19274WO

[0003] KIT OF SURGICAL INSTRUMENTS FOR FACILITATING A COMBINED USE OF TAKING A BRAIN BIOPSY FROM A PATIENT’S BRAIN AND OF INSERTING AN ANCHOR BOLT INTO A PATIENT’S SKULL

[0004] FIELD OF THE INVENTION

[0005] The present invention relates to a kit of surgical instruments for facilitating a combined use of taking a brain biopsy from a patient’s brain and of inserting an anchor bolt into a patient’s skull, to a method of assembling a kit of surgical instruments, and to a method of using such a kit.

[0006] TECHNICAL BACKGROUND

[0007] Cirq® is a robotic surgical system designed by Brainlab AG to assist surgeons precisely when and where support is needed. For cranial biopsies, the Cirq Robotic Alignment Module automatically aligns to patient-specific trajectories to guide tracked biopsy instruments and can thereby support increased patient comfort compared to frame-based cranial biopsy procedures.

[0008] Further, in many cranial procedures an anchor bolt must be placed into the skull of the patient. For example, laser interstitial thermal therapy requires such a placement of an anchor bolt in in the skull. Laser interstitial thermal therapy (LiTT) is a minimally invasive procedure that is most commonly used to treat epilepsy, brain tumors and a condition called radiation necrosis. The treatment uses heat to ablate (destroy) cancer cells, areas of dead tissue or a brain lesion where seizures begin. The procedure uses MRI guidance and takes several hours, followed by one or two nights in the hospital. Compared with those who undergo traditional open surgery, people who have LiTT may experience less pain and have a faster recovery.

[0009] As will become apparent from the present disclosure, the present invention can be used e.g. for combining the released SEEG and cranial Biopsy procedures with the Cirq robotic surgical system including drilling, both are products or are implemented in products of Brainlab AG.

[0010] In the context of their research in these medical fields, the inventors of the present invention have identified the need for providing an improved medical device which allows combining the taking of a brain biopsy from a patient’s skull in a first step with a placing the anchor in the patient’s skull in a second step. This is because the inventors have identified that differing diameter of anchor bolt, biopsy needle and drill bit would lead to exchange of guiding instruments, and that changing instruments could potentially lead to loss of trajectory.

[0011] Aspects of the present invention, examples and exemplary steps and their embodiments are disclosed in the following. Different exemplary features of the invention can be combined in accordance with the invention wherever technically expedient and feasible.

[0012] EXEMPLARY SHORT DESCRIPTION OF THE INVENTION

[0013] In the following, a short description of the specific features of the present invention is given which shall not be understood to limit the invention only to the features or a combination of the features described in this section.

[0014] According to the present invention, a kit of surgical instruments for facilitating a combined use of taking a brain biopsy from a patient’s brain and of inserting an anchor bolt into a patient’s skull is presented. As will detailed hereinafter, the kit comprises a tracking array, an alignment reduction tube, and an alignment guide tube, which will be described in detail hereinafter. As will become apparent from this disclosure, the presented kit of surgical instruments can be beneficially used for the combined navigated and robotic and / or computer-assisted biopsy and placement of an anchor bolt in a patient’s skull. In this regard, one core idea for this kit is that the diameters of the bone anchor and the tubes are matched to each other, enabling the goal of combining the procedure of taking a brain biopsy with e.g. a LITT procedure.

[0015] With the kit of surgical instruments presented herein, it is possible, despite differing diameters of the anchor bolt, the biopsy needle and the drill bit, to use the same guiding instrument and hence this kit of surgical instruments can avoid a change in instruments during the desired medical procedure. This reduces the risk of losing the trajectory during taking the biopsy and placing the anchor bolt for e.g. the subsequent LITT procedure. This will be explained in more detail hereinafter.

[0016] The tracking array used in the present invention is configured for being tracked by a tracking system. Moreover, the tracking array comprises a guide tube configured for receiving the alignment reduction tube. Thus, the alignment reduction tube can be inserted into to tracking array. The alignment reduction tube is configured for receiving the alignment guide tube. Thus, the alignment guide tube is configured for being inserted into the alignment reduction tube. As is apparent from this disclosure, the diameter of the instruments that can be introduced into the kit during a medical procedure can be variable. The separation of the kit into the three components tracking array, alignment reduction tube, and an alignment guide tube allows using at least two different diameters for inserting either another component of the kit or another surgical instrument, like e.g. a system for taking a brain biopsy or an anchor bolt and the respective screwdriver, as will be explained in more detail hereinafter. Thus, the tracking array, which can be tracked with a tracking device to determine and control the spatial position of the tracking array within e.g. an operating room of a hospital, can remain at a fixed and desired spatial position. This position may define the insertion trajectory into the patient’s skull for e.g. a biopsy and / or a LITT procedure.

[0017] The tracking array comprises a guide tube which is configured for receiving the alignment reduction tube, i.e., the alignment reduction tube can be inserted into said guide tube of the tracking array. The tracking array and the alignment reduction tube can be hold and / or positioned by for example a robotic surgical system like the Cirq®. Since the alignment reduction tube itself provides an inner hollow shaft into which an instrument or kit component can be inserted, the kit in this way provides a first diameter for medical instrument insertion along the trajectory defined by the well positioned tracking array. After having inserted the alignment guide tube into the alignment reduction tube and since the alignment guide tube itself provides an inner hollow shaft into which a medical instrument can be inserted, the kit in this way provides a second diameter for medical instrument insertion along the trajectory defined by the well positioned tracking array. As will be understood by the killed reader from the present disclosure, the presented kit of surgical instrument may make use of the matryoshka principle.

[0018] Therefore, while the fixed tracking array may thus securely preserve the desired trajectory for the medical workflow that is to be performed, the kit of surgical instrument, via the insertability of the alignment reduction tube and of the alignment guide tube into the kit, allows that medical instruments of variable diameter like a system for taking a brain biopsy or an anchor bolt can be inserted towards the patient’s skull and along the identical trajectory defined by the tracking array. More advantages and benefits will become be elucidated hereinafter in detail.

[0019] GENERAL DESCRIPTION OF THE INVENTION

[0020] In this section, a description of the general features of the present invention is given for example by referring to possible embodiments of the invention.

[0021] The present invention provides a method, (medical) system, computer program product, computer- readable medium, (other claim categories) according to the independent claims. Preferred embodiments are provided in the dependent claims. According to a first aspect of the present invention, a kit of surgical instruments for facilitating a combined use of taking a brain biopsy from a patient’s brain and of inserting an anchor bolt into a patient’s skull is presented. The kit of surgical instruments comprises: a tracking array, an alignment reduction tube, an alignment guide tube, wherein the tracking array is configured to be tracked by a tracking system, and wherein the tracking array comprises a guide tube configured for receiving the alignment reduction tube, wherein the alignment reduction tube is configured for receiving the alignment guide tube, wherein the alignment guide tube is configured for receiving a system for taking a brain biopsy from the patient’s brain, and wherein the alignment reduction tube is configured for receiving an anchor bolt for being inserted into the patient’s skull.

[0022] The kit of surgical instruments presented herein allows for the combination of brain biopsy and the insertion of an anchor bolt into a patient’s skull within one workflow. In particular, the kit of the present invention allows for combining the taking of a brain biopsy from a patient’s skull in a first step with the placing of an anchor in the patient’s skull in a second step, even when the diameter of the anchor bolt and of the biopsy needle do have differing diameter. Thus, the presented kit with its three main components and their respective geometrical configuration, as explained before and hereinafter, avoids an otherwise necessary exchange of guiding instruments. In this way, the presented kit of surgical instruments avoids a change of instruments and thus avoids or reduces the risk of losing the planned trajectory of the surgical planning. For example, the planned trajectory of the surgical planning is the middle axis of the guide tube of the tracking array, as will be described in more detail in the context of particular embodiments, for example the embodiment of Figure 2. As will be appreciated by the skilled reader, the guide tube of the tracking array can be used by the present invention as an instrument holder.

[0023] Furthermore, the kit can be integrated into a surgical navigation system for precise instrument guidance. The kit allows for diameter adaptation, and also for anchor placement verification, which will be described hereinafter in more detail.

[0024] The geometry of the kit components is configured such that the alignment guide tube can be inserted into the alignment reduction tube and the alignment reduction tube can be inserted into the guide tube of the tracking array. The system for taking a brain biopsy can be inserted into the alignment guide tube such that a brain biopsy from the patient’s brain with said system can be taken. Since said components are removably inserted into the respective other component, removing the system for taking a brain biopsy and the alignment guide tube from the alignment reduction tube and from the guide tube of the tracking array may take place after the biopsy while preserving the exact and tracked location of the tracking array with the working channel. Subsequently, the insertion of the anchor bolt into the alignment reduction tube for being drilled into the patient’s skull can take place.

[0025] As is apparent from the aforementioned disclosure, the guide tube of the tracking array is configured for receiving the alignment reduction tube, i.e. the alignment reduction tube can be inserted into the guide tube. The guide tube of the tracking array has a shaft with a virtual inner diameter, which is understood by the skilled reader as the working channel. In a preferred embodiment, the working channel is a round cylinder. Generally, the middle axis of the cylinder is the planned trajectory of the surgical planning. As will be described later in detail, especially in the context of the embodiments of the Figures, in a preferred embodiment the guide tube of the tracking array has a hollow cylindrical shape, the alignment reduction tube has a hollow cylindrical shape, and the alignment guide tube has a hollow cylindrical shape. But in other embodiments, also other shapes, in particular cross-sectional shapes of the components of the kit can be used.

[0026] Moreover, while metal used for surgical instruments is preferred, different other materials may be used for the components of the kit.

[0027] The kit has three main elements, i.e. the tracking array, the alignment reduction tube and the alignment guide tube. These elements have a respective ability, capability or configuration of being insertable into a particular other component of the kit, or a respective ability, capability or configuration for receiving a brain biopsy system and / or an anchor bolt. The brain biopsy system and the anchor bolt are not generally and necessarily part of the disclosed kit, but in particular embodiments the brain biopsy system and / or the anchor bolt are comprised by the kit of the present invention. As is apparent from the present disclosure, the inner diameter of the guide tube of the tracking array may be larger than the inner diameter of the alignment reduction tube, which in turn may be larger than the diameter of the alignment guide tube.

[0028] As is clear to the skilled reader, the presented kit allows for guiding surgical instruments along a preplanned trajectory. With the presented kit, the fitting diameter is able to be changed without deviating from said trajectory. Especially Figures 1 and 2 and the respective descriptions are elucidating this. Placement of anchor bolts and / or mini bolts can be included in the guiding, as well as a bone anchor and depth tracked biopsy needle. The placed bone anchor trajectory can be verified with the presented kit. Guiding instruments can be registered within one step.

[0029] The kit of surgical instrument as presented herein can be used for example in the following sequence. In a first step instrument registration is carried out, i.e. the tracking array, the alignment reduction tube, and the alignment guide tube are registered in the navigation system / surgical navigation system used. Next, the alignment to the trajectory with the used robotic arm is done without instruments, i.e., the tracking array only. Next, the insertion of alignment reduction tube into the guide tube of the tracking array can be carried out. The user may then drill through this assembly into the skull of the patient. In an optional next step, the insertion of a bone anchor for biopsy is carried out. In another optional feature, a biopsy sample can be taken by inserting a brain biopsy system, including preferably a bone anchor and a biopsy needle, into the alignment guide tube, which is inserted into the alignment reduction tube. Thus, the alignment guide tube is configured for receiving the system for taking a brain biopsy from the patient’s brain. Next, the brain biopsy system as well as the alignment guide tube can be removed from the kit and hence the wider diameter of the alignment reduction tube is open such that e.g. a LITT anchor bolt can be inserted / introduced into the alignment reduction tube for screwing the LITT anchor bolt into the skull of the patient along the identical trajectory along which the brain biopsy was taken.

[0030] In other words, with the presented kit of surgical instruments an improved medical device is provided, which allows combining brain biopsy a first step with a placing the anchor in the patient’s skull in a second step while differing diameters exist for the anchor bolt, the biopsy needle and drill bit. This will also be elucidated in the context of the particular embodiment of Figure 1 . With the presented kit no exchange of guiding instruments is necessary beneficially increasing the accuracy of the planned surgery by not losing the planned trajectory.

[0031] According to an embodiment of the present invention, particular insertability, i.e. the configuration of particular components to be insertable into another component of the kit, is defined. In other embodiments, a relation between inner and outer diameter of kit components is precisely defined.

[0032] According to an embodiment of the present invention, the alignment reduction tube is removably insertable into the guide tube of the tracking array.

[0033] When being inserted into the guide tube of the tracking array, the alignment reduction tube is movably but firmly hold in the guide tube, and it can be removed after usage from the guide tube.

[0034] According to an embodiment of the present invention, the alignment guide tube is removably insertable into the alignment reduction tube.

[0035] When being inserted into the alignment reduction tube of the tracking array, the alignment guide tube is movably but firmly hold in the alignment reduction tube, and it can be removed after usage from the alignment reduction tube. According to an embodiment of the present invention, an inner diameter of the guide tube of the tracking array equals an outer diameter of the alignment reduction tube.

[0036] As will be appreciated by the skilled reader, this diameter relation between the diameter of the guide tube and the outer diameter of the alignment reduction tube still allows, of course, for the insertion of the alignment reduction tube into the into the guide tube. But in order to avoid unnecessary space or air in between these two elements, the diameters may be optimized for a realizing tight fit between these two elements.

[0037] According to an embodiment of the present invention, an inner diameter of the alignment reduction tube equals an outer diameter of the alignment guide tube.

[0038] This diameter relation between the inner diameter of the alignment reduction tube and the outer diameter of the alignment guide tube still allows, of course, for the insertion of the alignment guide tube into the into the alignment reduction tube. But in order to avoid unnecessary space or air in between these two elements, the diameters may be optimized for a realizing tight fit between these two elements.

[0039] According to an embodiment of the present invention, an inner diameter of the alignment reduction tube equals an outer diameter of an anchor bolt and / or equals an outer diameter of a screwdriver for inserting the anchor bolt into the patient’s skull.

[0040] This diameter relation between the inner diameter of the alignment reduction tube and the outer diameter of the anchor bolt / screwdriver still allows, of course, for the insertion of the anchor bolt / screwdriver into the alignment reduction tube. But in order to avoid unnecessary space or air in between these elements, the diameters may be optimized for a realizing tight fit between these two elements.

[0041] According to an embodiment of the present invention, an inner diameter of the alignment guide tube equals an outer diameter of the system for taking a brain biopsy from a patient’s brain.

[0042] As will be appreciated by the skilled reader, this diameter relation between the inner diameter of the alignment guide tube and the outer diameter of the biopsy system still allows, of course, for the insertion of the biopsy system into the alignment guide tube. But in order to avoid unnecessary space or air in between these elements, the diameters may be optimized for a realizing tight fit between these two elements. According to an embodiment of the present invention, the alignment reduction tube and / or the alignment guide tube comprises a locking mechanism for spatially locking the alignment reduction tube relative to the alignment guide tube.

[0043] The locking mechanism may be embodied in various different ways, besides a Bayonet mechanism also a thread engagement may be used. Alternatively, the locking mechanism using protrusions and notches, into which the protrusions engage during locking, may be used. Also other variants of locking mechanism can of course be used.

[0044] According to an embodiment of the present invention, the locking mechanism locks the alignment reduction tube and the alignment guide tube regarding a rotational movement and / or a translational movement between the alignment reduction tube and the alignment guide tube.

[0045] According to an embodiment of the present invention, the locking mechanism is a Bayonet mechanism provided at the alignment reduction tube and the alignment guide tube.

[0046] A particular embodiment of this Bayonet mechanism can be seen in Figures 1 to 4b. If desired, the proximal end of the alignment reduction tube may comprise the female part of the Bayonet mechanism including a notch or recess like section into which the pin-shaped male part located at the alignment guide tube can be inserted for locking the two tubes relative to each other.

[0047] According to an exemplary embodiment of the present invention, the alignment guide tube comprises a hollow shaft for receiving the system for taking the brain biopsy from the patient’s brain.

[0048] A particular embodiment thereof is shown in Figures 4a and 4b depicting the hollow shaft 402 having a diameter of the biopsy system, which can be part of this embodiment.

[0049] According to an exemplary embodiment of the present invention, wherein the hollow shaft comprises at a distal end thereof one or more teeth or protrusions for fixing the alignment guide tube at the patient’s skull.

[0050] The alignment guid tube comprises a hollow shaft and at a distal end thereof comprises preferably a plurality of teeth or protrusions for fixing the alignment guide tube at the patient’s skull, see also the particular embodiment of Figures 4a and 4b. This improves the spatially fixation of the combination of the tracking array 101 and the tubes 102, 103 relative to the skull. Such sharp teeth support bone contact during handling before drilling. The alignment guid tube may additionally have one, two or more windows for cooling and removing debris during drilling. According to an exemplary embodiment of the present invention, the kit comprises the system for taking the brain biopsy from the patient’s brain.

[0051] This embodiment adds the system for taking the brain biopsy to the kit and defines how its components interact with the other components of the claimed kit.

[0052] In a particular embodiment, the system may comprise a biopsy needle and an alignment bone ancho, as is known by the skilled reader. Preferably, the alignment guide tube is configured for receiving the alignment bone anchor by insertion, and the alignment bone anchor is configured for receiving the biopsy needle by insertion.

[0053] In another embodiment, the kit comprises the anchor bolt and / or a screwdriver for inserting the anchor bolt into the patient’s skull.

[0054] According to another aspect of the present invention a method of assembling a kit of surgical instruments for facilitating a combined taking of a brain biopsy from a patient’s brain and an inserting of an anchor bolt into a patient’s skull is presented. The method comprises the step of providing a tracking array configured for being tracked by a tracking system (S1), providing an alignment reduction tube (S2), providing an alignment guide tube (S3), inserting the alignment guide tube into the alignment reduction tube (S4), and inserting the alignment reduction tube into a guide tube of the tracking array (S5).

[0055] Such an assembled configuration of the kit can be gathered from e.g. Figure 2. The assembling process has been detailed hereinbefore and will detailed in again in the context of the description of Figure 1.

[0056] In preferred method embodiment, the alignment reduction tube is locked relative to the alignment guide tube using a locking mechanism of the alignment reduction tube and / or of the alignment guide tube for spatially locking the alignment reduction tube and the alignment guide tube relative to each other.

[0057] According to another method embodiment, the locking mechanism locks the alignment reduction tube and the alignment guide tube regarding a rotational movement and / or a translational movement between the alignment reduction tube and the alignment guide tube.

[0058] According to another method embodiment, the locking mechanism is a Bayonet for assembling the alignment reduction tube and the alignment guide tube. Similar to the embodiments of the kit that were detailed before, in the following method embodiments the insertability, i.e. the configuration of particular components to be removably insertable into another component of the kit, will be detailed. This also entail specific definitions the inner and outer diameter of the kit components.

[0059] According to another embodiment, the alignment reduction tube is removably inserted into the guide tube of the tracking array.

[0060] According to another embodiment, the alignment guide tube is removably inserted into the alignment reduction tube.

[0061] According to another embodiment, an inner diameter of the guide tube of the tracking array equals an outer diameter of the alignment reduction tube.

[0062] According to another embodiment, an inner diameter of the alignment reduction tube equals an outer diameter of the alignment guide tube.

[0063] According to another embodiment, an inner diameter of the alignment reduction tube equals an outer diameter of an anchor bolt and / or equals an outer diameter of a screwdriver for inserting the anchor bolt into the patient’s skull.

[0064] According to another embodiment, wherein an inner diameter of the alignment guide tube equals an outer diameter of the system for taking a brain biopsy from a patient’s brain.

[0065] According to another aspect of the present invention, a system for facilitating a combined use of taking a brain biopsy from a patient’s brain and of inserting an anchor bolt into a patient’s skull is presented. The system comprises a kit of surgical instruments as presented herein, a tracking system for tracking the tracking array of the kit of surgical instruments, and a surgical navigation system.

[0066] In this embodiment, the kit can be integrated into the surgical navigation system for precise instrument guidance. As one example, a camera of the tracking system is used for spatially tracking the tracking array of the kit. The surgical navigation system may also comprise a display on which image information can be displayed to the user while using the tracked kit. A non-limiting example is depicted in Figure 2. According to another aspect of the present invention, a method of using a kit of surgical instruments for combining taking of a brain biopsy from a patient’s brain and inserting an anchor bolt into a patient’s skull is presented. The method comprises the steps providing a kit of surgical instruments, the kit comprising: a tracking array configured for being tracked by a tracking system, an alignment reduction tube, an alignment guide tube.

[0067] And the method comprising the steps inserting the alignment guide tube into the alignment reduction tube, inserting the alignment reduction tube into a guide tube of the tracking array, inserting a system for taking a brain biopsy into the alignment guide tube, taking a brain biopsy from the patient’s brain with said system for taking a brain biopsy, removing the system for taking a brain biopsy and the alignment guide tube from the alignment reduction tube and from the guide tube of the tracking array; and inserting an anchor bolt for being inserted into the patient’s skull into the alignment reduction tube.

[0068] The features and advantages outlined above in the context of the method similarly apply to the system, computer program product, and computer-readable medium of the present disclosure (or other claim categories).

[0069] For example, the invention does not involve or in particular comprise or encompass an invasive step which would represent a substantial physical interference with the body requiring professional medical expertise to be carried out and entailing a substantial health risk even when carried out with the required professional care and expertise. For example, the invention does not comprise a step of positioning a medical implant in order to fasten it to an anatomical structure or a step of fastening the medical implant to the anatomical structure or a step of preparing the anatomical structure for having the medical implant fastened to it. More particularly, the invention does not involve or in particular comprise or encompass any surgical or therapeutic activity. The invention is instead directed as applicable to [image analysis of medical images / navigation applications / support tools supporting a user in technical tasks...]. Forthis reason alone, no surgical or therapeutic activity and in particular no surgical or therapeutic step is necessitated or implied by carrying out the invention.

[0070] DEFINITIONS

[0071] In this section, definitions for specific terminology used in this disclosure are offered which also form part of the present disclosure.

[0072] Registering The n-dimensional image of a body is registered when the spatial location of each point of an actual object within a space, for example a body part in an operating theatre, is assigned an image data point of an image (CT, MR, etc.) stored in a navigation system.

[0073] Image registration

[0074] Image registration is the process of transforming different sets of data into one co-ordinate system. The data can be multiple photographs and / or data from different sensors, different times or different viewpoints. It is used in computer vision, medical imaging and in compiling and analysing images and data from satellites. Registration is necessary in order to be able to compare or integrate the data obtained from these different measurements. Further, in image or patient registration the virtual data are brought together with the anatomical physical world so that tracked instruments can be used on the (human) anatomy and are displayed on the patient image set at the navigation system.

[0075] Marker

[0076] It is the function of a marker to be detected by a marker detection device (for example, a camera or an ultrasound receiver or analytical devices such as CT or MRI devices) in such a way that its spatial position (i.e. its spatial location and / or alignment) can be ascertained. The detection device is for example part of a navigation system. The markers can be active markers. An active marker can for example emit electromagnetic radiation and / or waves which can be in the infrared, visible and / or ultraviolet spectral range. A marker can also however be passive, i.e. can for example reflect electromagnetic radiation in the infrared, visible and / or ultraviolet spectral range or can block x-ray radiation. To this end, the marker can be provided with a surface which has corresponding reflective properties or can be made of metal in order to block the x-ray radiation. It is also possible for a marker to reflect and / or emit electromagnetic radiation and / or waves in the radio frequency range or at ultrasound wavelengths. A marker preferably has a spherical and / or spheroid shape and can therefore be referred to as a marker sphere; markers can however also exhibit a cornered, for example cubic, shape.

[0077] Marker device

[0078] A marker device can for example be a reference star or a pointer or a single marker or a plurality of (individual) markers which are then preferably in a predetermined spatial relationship. A marker device comprises one, two, three or more markers, wherein two or more such markers are in a predetermined spatial relationship. This predetermined spatial relationship is for example known to a navigation system and is for example stored in a computer of the navigation system.

[0079] In another embodiment, a marker device comprises an optical pattern, for example on a two- dimensional surface. The optical pattern might comprise a plurality of geometric shapes like circles, rectangles and / or triangles. The optical pattern can be identified in an image captured by a camera, and the position of the marker device relative to the camera can be determined from the size of the pattern in the image, the orientation of the pattern in the image and the distortion of the pattern in the image. This allows determining the relative position in up to three rotational dimensions and up to three translational dimensions from a single two-dimensional image.

[0080] The position of a marker device can be ascertained, for example by a medical navigation system. If the marker device is attached to an object, such as a bone or a medical instrument, the position of the object can be determined from the position of the marker device and the relative position between the marker device and the object. Determining this relative position is also referred to as registering the marker device and the object. The marker device or the object can be tracked, which means that the position of the marker device or the object is ascertained twice or more over time.

[0081] Marker holder

[0082] A marker holder is understood to mean an attaching device for an individual marker which serves to attach the marker to an instrument, a part of the body and / or a holding element of a reference star, wherein it can be attached such that it is stationary and advantageously such that it can be detached. A marker holder can for example be rod-shaped and / or cylindrical. A fastening device (such as for instance a latching mechanism) for the marker device can be provided at the end of the marker holder facing the marker and assists in placing the marker device on the marker holder in a force fit and / or positive fit.

[0083] Pointer

[0084] A pointer is a rod which comprises one or more - advantageously, two - markers fastened to it and which can be used to measure off individual co-ordinates, for example spatial co-ordinates (i.e. three-dimensional co-ordinates), on a part of the body, wherein a user guides the pointer (for example, a part of the pointer which has a defined and advantageously fixed position with respect to the at least one marker attached to the pointer) to the position corresponding to the co-ordinates, such that the position of the pointer can be determined by using a surgical navigation system to detect the marker on the pointer. The relative location between the markers of the pointer and the part of the pointer used to measure off co-ordinates (for example, the tip of the pointer) is for example known. The surgical navigation system then enables the location (of the three-dimensional co-ordinates) to be assigned to a predetermined body structure, wherein the assignment can be made automatically or by user intervention.

[0085] Navigation system

[0086] The present disclosure relates to and / or is applied in the context of a navigation system for computer-assisted surgery. This navigation system preferably comprises the aforementioned computer for processing the data provided in accordance with the computer implemented method as described in any one of the embodiments described herein. The navigation system preferably comprises a detection device for detecting the position of detection points which represent the main points and auxiliary points, in order to generate detection signals and to supply the generated detection signals to the computer, such that the computer can determine the absolute main point data and absolute auxiliary point data on the basis of the detection signals received. A detection point is for example a point on the surface of the anatomical structure which is detected, for example by a pointer. In this way, the absolute point data can be provided to the computer. The navigation system also preferably comprises a user interface for receiving the calculation results from the computer (for example, the position of the main plane, the position of the auxiliary plane and / or the position of the standard plane). The user interface provides the received data to the user as information. Examples of a user interface include a display device such as a monitor, or a loudspeaker. The user interface can use any kind of indication signal (for example a visual signal, an audio signal and / or a vibration signal). One example of a display device is an augmented reality device (also referred to as augmented reality glasses) which can be used as so-called "goggles" for navigating. A specific example of such augmented reality glasses is Google Glass (a trademark of Google, Inc.). An augmented reality device can be used both to input information into the computer of the navigation system by user interaction and to display information outputted by the computer.

[0087] The present disclosure also relates to and / or is applied in the context of a navigation system for computer-assisted surgery, comprising: a computer for processing the absolute point data and the relative point data; a detection device for detecting the position of the main and auxiliary points in order to generate the absolute point data and to supply the absolute point data to the computer; a data interface for receiving the relative point data and for supplying the relative point data to the computer; and a user interface for receiving data from the computer in order to provide information to the user, wherein the received data are generated by the computer on the basis of the results of the processing performed by the computer. Surgical navigation system

[0088] A navigation system, such as a surgical navigation system, is understood to mean a system which can comprise: at least one marker device; a transmitter which emits electromagnetic waves and / or radiation and / or ultrasound waves; a receiver which receives electromagnetic waves and / or radiation and / or ultrasound waves; and an electronic data processing device which is connected to the receiver and / or the transmitter, wherein the data processing device (for example, a computer) for example comprises a processor (CPU) and a working memory and advantageously an indicating device for issuing an indication signal (for example, a visual indicating device such as a monitor and / or an audio indicating device such as a loudspeaker and / or a tactile indicating device such as a vibrator) and a permanent data memory, wherein the data processing device processes navigation data forwarded to it by the receiver and can advantageously output guidance information to a user via the indicating device. The navigation data can be stored in the permanent data memory and for example compared with data stored in said memory beforehand.

[0089] BRIEF DESCRIPTION OF THE DRAWINGS

[0090] In the following, the invention is described with reference to the appended figures which give background explanations and represent specific embodiments of the invention. The scope of the invention is however not limited to the specific features disclosed in the context of the figures, wherein

[0091] Fig. 1 schematically illustrates one embodiment of a kit of surgical instruments for facilitating a combined use of taking a brain biopsy from a patient’s brain and of inserting an anchor bolt into a patient’s skull according to the present disclosure;

[0092] Fig. 2 schematically illustrates one embodiment of a kit of surgical instruments for facilitating a combined use of taking a brain biopsy from a patient’s brain and of inserting an anchor bolt into a patient’s skull according to the present disclosure;

[0093] Fig. 3 schematically illustrates an alignment reduction tube according to the present disclosure;

[0094] Figs. 4a and 4b schematically illustrate an alignment guide tube according to the present disclosure;

[0095] Fig. 5 schematically illustrates a bone anchor 500 according to the present disclosure; and Fig. 6 schematically illustrates a flow diagram of a method of assembling a kit of surgical instruments for facilitating a combined taking of a brain biopsy from a patient’s brain and an inserting of an anchor bolt into a patient’s skull according to the present disclosure.

[0096] DESCRIPTION OF EMBODIMENTS

[0097] Figure 1 schematically shows a kit of surgical instruments 100 for facilitating a combined use of taking a brain biopsy from a patient’s brain and of inserting an anchor bolt into a patient’s skull according to the present disclosure. The kit 100 comprises a tracking array 101 , an alignment reduction tube 102, an alignment guide tube 103. The tracking array 101 is configured to be tracked by a tracking system (not shown) and it comprises a guide tube 108 configured for receiving the alignment reduction tube 102 by insertion of the alignment reduction tube into the guide tube 108. The alignment reduction tube 102 is configured for receiving the alignment guide tube 103 by insertion of the alignment guide tube into alignment reduction tube 102. The alignment guide tube is configured for receiving a system for taking a brain biopsy from the patient’s brain. This brain biopsy system may include preferably a bone anchor 104 or alignment bone anchor 104 and a biopsy needle (not shown), which can be inserted into the alignment guide tube 103. Further, the alignment reduction tube 102 is configured for receiving the anchor bolt 107 and a respective screwdriver for being inserted into the patient’s skull. As clear from the present disclosure, the diameter of the anchor bolt, which is to be inserted into the alignment reduction tube 102 is different, i.e. is larger, than the diameter of the biopsy needle, which is to be inserted into the bone anchor 104. The kit of surgical instruments 100 with the different diameters of the alignment reduction tube 102 and of the alignment guide tube 103 allows to subsequently insert the biopsy needle and the bone anchor 107 having different diameters into one well positioned and tracked device. Thus, the presented kit 100 with its three components 101 , 102 and 103 and their respectively adapted diameters allowing for an insertion into another, avoids an otherwise necessary exchange of guiding instruments. In this way, the presented kit of surgical instruments 100 avoids or reduces the risk of losing the planned trajectory of the surgical planning. For example, the planned trajectory of the surgical planning is the middle axis of the guide tube 108 of the tracking array 101. One advantage of the presented kit 100 is that it allows for taking a brain biopsy and the placement of the bone anchor 107 for a LITT procedure without having to move, reposition or exchange the tracking array 101. In this embodiment, element 106 is the Cirq Robotic Instrument Holder. It is attached at the Cirq Robotic Kinematic Unit and holds the Cirq Robotic Tracking Array.

[0098] The following sequence may be carried out when using the kit 100. First, a registration of the instruments shown in Figure 1 can be carried out. The two tubes 102 and 103, i.e. the alignment reduction tube 102 and the alignment guide tube 103, are connected with a bayonet mechanism and are then both inserted into the guide tube 108 of the tracking array 101 until they reach the stop. The tracking array 101 in this embodiment comprises a locking mechanism for locking the two combined tubes 102 and 103 in this stop position. Further, a calibration matrix and software can be used while the tracking array 101 is inserted into an opening, in which opening the tracking array 101 can be rotated for visibility of the camera of the tracking system until the registration is completed.

[0099] The tracking array 101 together with the two combined tubes 102 and 103 can then be connected and fixed to the kinematic unit of e.g. a surgical robot. As was mentioned hereinbefore, the tracking array 101 together with the inserted alignment reduction tube and alignment guide tube can be hold and / or positioned by for example a robotic surgical system like the Cirq®. The coarse positioning of the robot with the attached tracking array 101 and the combined tubes 102, 103 can be done e.g. manually by a user and the fine positioning can be done by the robot. When the tracking array 101 and the combined tubes 102, 103 are well positioned, a working channel relative to the patient’s skull is defined. As is clear to the skilled reader, the guide tube of the tracking array has a shaft with a virtual inner diameter, which is to be understood as the working channel. In a preferred embodiment, the working channel is a round cylinder. The combined tubes 102, 103, which are locked together by the Bayonet mechanism, can then be contacted to the surface of the patient’s skull. The alignment guid tube 103 comprises a hollow shaft and at a distal end thereof comprises a plurality of teeth or protrusions for fixing the alignment guide tube 103 at the patient’s skull, see also the particular embodiment of Figures 4a and 4b. This improves in spatially fixing the combination of the tracking array 101 and the tubes 102, 103 relative to the skull. Now the user may drill into the patient’s skull at this fixed and tracked location. This can be done by inserting a drilling device 105a into a hollow shaft of the alignment guide tube 103. The drilling device 105a may comprise a drill stop 105b for precisely defining the drill depth into the skull.

[0100] At his point in time the user can decide whether he / she wants to take a biopsy from the patient’s brain while using the fixed location and thus being sure that one is working along the planned surgical trajectory defined by inter alia the guide tube 108. For this task a bone anchor 104 can be introduced into the hollow shaft of the alignment guide tube 103 and can be drilled into the skull of the patient. The bone anchor 104 comprises a hollow shaft adapted for the insertion of a biopsy needle (not shown) and comprises an outer thread around its outer surface for facilitating drilling of the bone anchor into the skull bone. Now a biopsy can be inserted into the hollow shaft of the bone anchor 104 and brain tissue can be extracted by the user. After completing the brain biopsy, the needle removed, and the bone anchor can be drilled out of the skull. Further, the two tubes 102 and 103, i.e. the alignment reduction tube 102 and the alignment guide tube 103, can be unlocked by opening the Bayonet mechanism allowing to remove the alignment guide tube 103 from the alignment reduction tube 102, which still remains in the guide tube 108. At this point in time the anchor bolt 107 the alignment reduction (101) tube and thus into the can be inserted into the patient’s skull

[0101] Figure 2 schematically shows a kit of surgical instruments 200 for facilitating a combined use of taking a brain biopsy from a patient’s brain and of inserting an anchor bolt into a patient’s skull is presented. The kit 200 is integrated into a surgical navigation system 208 for precise instrument guidance. Figure 2 depicts a camera 206, which is part of the tracking system 207 for spatially tracking the tracking array 201 of the kit 200. The surgical navigation system 208 also comprise a display 209 on which image information can be displayed to the user while using the tracked kit 200. The kit also allows for diameter adaptation, and also for anchor placement verification. The kit 200 comprises besides the tracking array 201 , an alignment reduction tube 202, and an alignment guide tube 203. The kit 200 can be beneficially used for the combined navigated and robotic and / or computer-assisted biopsy and placement of an anchor bolt in a patient’s skull. In this regard, one core advantage of this kit 200 is that the diameters of the bone anchor 204 and the tubes 202, 203 are matched to each other, enabling the goal of combining the procedure of taking a brain biopsy with e.g. a LITT procedure. It is thus possible, despite differing diameters of the anchor bolt 204, the biopsy needle (not shown) and the drill bit 205a including the drill stop 205b, to use the same guiding instrument and hence this kit of surgical instruments 200 can avoid a change in instruments during the desired medical procedure. This reduces the risk of losing the trajectory during taking the biopsy and placing the anchor bolt for e.g. the subsequent LITT procedure.

[0102] In Figures 3, 4a and 4b a particular embodiment of the Bayonet locking mechanism can be seen. At the proximal end 301 of the alignment reduction tube 300 may comprise the female part 302 of the Bayonet mechanism including a notch 303 or recess like section 303 into which the respective pin-shaped male part 401 located at the alignment guide tube 400 can be inserted for locking the two tubes 300, 400 relative to each other. While Figures 3 and 4a show front views of the alignment reduction tube 300 and the alignment guide tube 400, Figure 4b shows a cross section along the hollow shaft of the alignment guide tube 400. Said hollow shaft comprises at a distal end thereof a plurality of teeth 403 or protrusions 403 for fixing the alignment guide tube 404 at the patient’s skull.

[0103] The alignment reduction tube 300 shown in Figure 3 comprises rips for grip 304 and has an exemplary outer diameter of 10 mm to be guided and hold by guide tube of the tracking array of the kit. Tube 300 also comprises a smooth transition phase at the distal end for easy insertion into tracking array. Tube 300 also comprises a welded notch to prevent rotation during drilling and anchor bolt insertion. The Bayonet at the proximal end is for assembly with the alignment guide tube for rotational and axial holding. The alignment guide tube 400 shown in Figures 4a and 4b has a Bayonet feature for tube assembly achieving rotational and axial holding. In this example, the tube 400 has an outer diameter of 8 mm to be guided by inner part of the hollow shaft of the alignment reduction tube 300. Tube 400 comprises sharp teeth 403 to support bone contact during handling before drilling and has two symmetric windows 404 for cooling and removing debris during drilling.

[0104] Figure 5 schematically shows a bone anchor 500 with a shaft 501 and at the distal end the cranial drill bit variant 502 can be seen.

[0105] Figure 6 schematically shows a flow diagram of a method of assembling a kit of surgical instruments for facilitating a combined taking of a brain biopsy from a patient’s brain and an inserting of an anchor bolt into a patient’s skull. The method comprises the steps of providing a tracking array configured for being tracked by a tracking system (S1), providing an alignment reduction tube (S2), providing an alignment guide tube (S3), inserting the alignment guide tube into the alignment reduction tube (S4), and inserting the alignment reduction tube into a guide tube of the tracking array (S5).

[0106] While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered exemplary and not restrictive. The invention is not limited to the disclosed embodiments. In view of the foregoing description and drawings it will be evident to a person skilled in the art that various modifications may be made within the scope of the invention, as defined by the claims.

Claims

Brainlab AGAttorney’s File: B19274WOCLAIMS1 . Kit of surgical instruments (100) for facilitating a combined use of taking a brain biopsy from a patient’s brain and of inserting an anchor bolt into a patient’s skull, the kit of surgical instruments comprising a tracking array (101), an alignment reduction tube (102), an alignment guide tube (103), wherein the tracking array (101) is configured to be tracked by a tracking system, and wherein the tracking array comprises a guide tube (108) configured for receiving the alignment reduction tube (102), wherein the alignment reduction tube (102) is configured for receiving the alignment guide tube (103), wherein the alignment guide tube (103) is configured for receiving a system for taking a brain biopsy from the patient’s brain, and wherein the alignment reduction tube (102) is configured for receiving an anchor bolt (107) for being inserted into the patient’s skull.

2. Kit of surgical instruments according to claim 1 , wherein the alignment reduction tube is removably insertable into the guide tube of the tracking array.

3. Kit of surgical instruments according to claim 1 or 2, wherein the alignment guide tube is removably insertable into the alignment reduction tube.

4. Kit of surgical instruments according to any of the preceding claims, wherein an inner diameter of the guide tube of the tracking array equals an outer diameter of the alignment reduction tube.

5. Kit of surgical instruments according to any of the preceding claims, wherein an inner diameter of the alignment reduction tube equals an outer diameter of the alignment guide tube.

6. Kit of surgical instruments according to any of the preceding claims,wherein an inner diameter of the alignment reduction tube equals an outer diameter of an anchor bolt and / or equals an outer diameter of a screwdriver for inserting the anchor bolt into the patient’s skull.

7. Kit of surgical instruments according to any of the preceding claims, wherein an inner diameter of the alignment guide tube equals an outer diameter of the system for taking a brain biopsy from a patient’s brain.

8. Kit of surgical instruments according to any of the preceding claims, wherein the alignment reduction tube and / or the alignment guide tube comprises a locking mechanism for spatially locking the alignment reduction tube relative to the alignment guide tube.

9. Kit of surgical instruments according to claim 8, wherein the locking mechanism locks the alignment reduction tube and the alignment guide tube regarding a rotational movement and / or a translational movement between the alignment reduction tube and the alignment guide tube.

10. Kit of surgical instruments according to claim 8 or 9, wherein the locking mechanism is a Bayonet mechanism provided at the alignment reduction tube and the alignment guide tube.

11. Kit of surgical instruments according to any of the preceding claims, wherein the alignment guide tube comprises a hollow shaft for receiving the system for taking the brain biopsy from the patient’s brain.

12. Kit of surgical instruments according to claim 11 , wherein the hollow shaft comprises at a distal end thereof one or more teeth or protrusions for fixing the alignment guide tube at the patient’s skull.

13. Kit of surgical instruments according to any of the preceding claims, the kit comprising the system for taking the brain biopsy from the patient’s brain.

14. Kit of surgical instruments according to claim 13, wherein the system for taking the brain biopsy comprises a biopsy needle and an alignment bone anchor.

15. Kit of surgical instruments according to claim 14,wherein the alignment guide tube is configured for receiving the alignment bone anchor by insertion, and wherein the alignment bone anchor is configured for receiving the biopsy needle by insertion.

16. Kit of surgical instruments according to any of the preceding claims, the kit comprising the anchor bolt, and preferably a screwdriver for inserting the anchor bolt into the patient’s skull.

17. Method of assembling a kit of surgical instruments (100) for facilitating a combined taking of a brain biopsy from a patient’s brain and an inserting of an anchor bolt into a patient’s skull, the method comprising providing a tracking array configured for being tracked by a tracking system (S 1 ), providing an alignment reduction tube (S2), providing an alignment guide tube (S3), inserting the alignment guide tube into the alignment reduction tube (S4), and inserting the alignment reduction tube into a guide tube of the tracking array (S5).

18. Method according to claim 17, locking the alignment reduction tube relative to the alignment guide tube using a locking mechanism of the alignment reduction tube and / or of the alignment guide tube for spatially locking the alignment reduction tube and the alignment guide tube relative to each other.

19. Method according to claim 18, wherein the locking mechanism locks the alignment reduction tube and the alignment guide tube regarding a rotational movement and / or a translational movement between the alignment reduction tube and the alignment guide tube.

20. Method according to claim 18 or 19, wherein the locking mechanism is a Bayonet for assembling the alignment reduction tube and the alignment guide tube.21 . Method according to any of the claims 15 to 20, wherein the alignment reduction tube is removably inserted into the guide tube of the tracking array.

22. Method according to any of the claims 15 to 21 , wherein the alignment guide tube is removably inserted into the alignment reduction tube.

23. Method according to any of the claims 15 to 22, wherein an inner diameter of the guide tube of the tracking array equals an outer diameter of the alignment reduction tube.

24. Method according to any of the claims 15 to 23, wherein an inner diameter of the alignment reduction tube equals an outer diameter of the alignment guide tube.

25. Method according to any of the claims 15 to 24, wherein an inner diameter of the alignment reduction tube equals an outer diameter of an anchor bolt and / or equals an outer diameter of a screwdriver for inserting the anchor bolt into the patient’s skull.

26. Method according to any of the claims 15 to 25, wherein an inner diameter of the alignment guide tube equals an outer diameter of the system for taking a brain biopsy from a patient’s brain.

27. System for facilitating a combined use of taking a brain biopsy from a patient’s brain and of inserting an anchor bolt into a patient’s skull, the system comprising:- a kit of surgical instruments according to any of claims 1 to 16,- a tracking system for tracking the tracking array of the kit of surgical instruments, and- a surgical navigation system.

28. Method of using a kit of surgical instruments for combining taking of a brain biopsy from a patient’s brain and inserting an anchor bolt into a patient’s skull, the method comprising the steps providing a kit of surgical instruments, the kit comprising: a tracking array configured for being tracked by a tracking system, an alignment reduction tube, an alignment guide tube, and the method comprising the step inserting the alignment guide tube into the alignment reduction tube, inserting the alignment reduction tube into a guide tube of the tracking array, inserting a system for taking a brain biopsy into the alignment guide tube, taking a brain biopsy from the patient’s brain with said system for taking a brain biopsy, removing the system for taking a brain biopsy and the alignment guide tube from the alignment reduction tube and from the guide tube of the tracking array; and inserting an anchor bolt for being inserted into the patient’s skull into the alignment reduction tube.

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