Sterilizable Surgical Device with Battery Switch

Abstract

A surgical tracker assembly for use in a navigation system. The tracker assembly includes a tracker body defining a chamber configured to receive a printed circuit board (PCB), the tracker body including a plurality of markers that can be actively energized via the PCB. A plurality of openings formed in the tracker body and at least one channel formed in the tracker body extend between the chamber and one of the channels defined by the tracker body. Each of the markers is visible through one of the plurality of openings in the tracker body. The tracker body is configured to be sterilizable with the PCB located within the chamber of the tracker body, and the at least one channel is configured to allow a sterilizing fluid to pass into and out of the chamber of the tracker body during sterilization. The PCB may also include a sterilization-resistant protective coating.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and the entire benefit of U.S. Provisional Patent Application No. 63 / 333,676, filed April 22, 2022, which is expressly incorporated herein by reference. [Background technology]

[0002] Navigation systems are frequently used to assist medical professionals in performing various surgical procedures, including neurosurgery and orthopedic procedures. To this end, a surgeon may use a navigation system to track, monitor, or otherwise locate one or more tools, surgical instruments, and / or portions of a patient's anatomy within a common frame of reference. Typically, the tools and / or surgical instruments are tracked along with the anatomy, and their relative motion is depicted on a display. Often, a tracker is attached to or otherwise incorporated into the tracked object. A localizer cooperates with tracking elements (e.g., fiducials, markers, etc.) coupled to the tracker to monitor the tracker and determine the position and / or orientation of the tracked object.

[0003] Many types of navigation systems may utilize active trackers that require a power source for the operation of the tracker's components, e.g., activation of markers on the tracker. Many active trackers utilize a battery as a power source. However, if the battery is not replaceable or if the battery is not removable from the tracker, sterilization of the tracker may destroy the battery, shorten the battery's achievable useful life, and / or force the tracker into a "disposable" tracker that must be discarded. Furthermore, even if the battery is removable from a conventional tracker, the tracker's internal components are typically not well adapted to withstand the sterilization process. In such cases, sensitive internal components of the tracker must be removed prior to sterilization to ensure that the internal components are not damaged. Removing these components is a time-consuming process that increases complexity and cost. Thus, there remains a need in the art to overcome at least the above deficiencies. Summary of the Invention

[0004] This Summary introduces a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to limit the scope of the claimed subject matter, nor is it intended to identify key features or essential features of the claimed subject matter.

[0005] According to a first aspect, a surgical tracker for identifying and / or tracking a surgical instrument is provided. The surgical tracker includes a tracker body that may include a first surface, a second surface spaced apart from the first surface and facing the first surface, and a side surface connected between the first surface and the second surface, the tracker body defining a chamber formed within the first surface, the second surface, and the side surface. The tracker also includes a plurality of openings formed in the first surface. The tracker also includes at least one channel formed in the tracker body, the at least one channel extending between the chamber and one of the surfaces of the tracker body. The tracker also includes a printed circuit board (PCB) configured to support a plurality of markers that are actively energizable via the PCB, the PCB being within the chamber of the tracker body, each of the markers being visible through one of the plurality of openings in the tracker body. The tracker also includes a configuration in which the PCB is positioned within a chamber of the tracker body such that the tracker body is sterilizable, and at least one channel is configured to allow sterilizing fluid to pass into and out of the chamber of the tracker body during sterilization.

[0006] According to a second aspect, a surgical tracker is provided. The surgical tracker also includes a tracker body defining an internal chamber. The tracker also includes a plurality of openings extending through the tracker body into the internal chamber. The tracker also includes at least one channel extending through the tracker body into the internal chamber, the at least one channel configured to allow fluid to pass into and out of the internal chamber. The tracker also includes a printed circuit board (PCB) within the internal chamber and configured to support a plurality of tracking markers, each tracking marker visible through and substantially occupying one of the openings.

[0007] According to a third aspect, a surgical tracker is disclosed. The surgical tracker assembly also includes a tracker body defining an internal chamber and a battery opening, with a first contact and a second contact disposed in the battery opening. The assembly also includes a channel formed in the tracker body, the channel extending from the internal chamber through an exterior surface of the tracker body and configured to allow sterilizing fluid to pass into and out of the internal chamber of the tracker body during sterilization. The assembly also includes a printed circuit board (PCB) at least partially disposed in the internal chamber, the PCB supporting the at least one marker, the PCB connected to the first contact and the second contact. The assembly also includes a battery assembly removably coupleable to the tracker body and configured to be securely seated in the battery opening, the battery assembly may include a first battery contact configured to engage with the first contact and a second battery contact configured to engage with the second contact to form an electrical connection with the PCB to allow the PCB to actively energize the at least one marker.

[0008] According to a fourth aspect, a surgical tracker is disclosed. The surgical tracker assembly also includes a tracker body defining an internal chamber. The assembly also includes a channel extending through the tracker body into the internal chamber, the channel configured to allow sterilizing fluid to pass into and out of the internal chamber. The assembly also includes a printed circuit board (PCB) at least partially disposed within the internal chamber, the PCB supporting at least one tracking marker. The assembly also includes the PCB being coated with a parylene coating to protect the PCB from sterilizing fluid entering the internal chamber of the tracker body through the channel during sterilization.

[0009] According to a fifth aspect, a surgical tracker assembly is provided. The surgical tracker assembly includes a tracker body defining an internal chamber and a battery opening, with a first contact and a second contact disposed in the battery opening. A printed circuit board (PCB) is at least partially disposed within the internal chamber, with the PCB supporting at least one marker, with the PCB connected to the first contact and the second contact. The battery assembly includes a first battery contact and a second battery contact. The battery assembly is configured to be installed in the battery opening at a first position, with the first battery contact of the battery assembly engaged with the first contact and the second battery contact of the battery assembly disengaged from the second contact, thereby forming an open circuit between the battery assembly and the PCB. The battery assembly is configured to rotate from the first position to a second position when installed in the battery opening, with the first battery contact of the battery assembly engaged with the first contact and the second battery contact of the battery assembly engaged to form a closed circuit between the battery assembly and the PCB for energizing the PCB.

[0010] According to a sixth aspect, a method of sterilizing a surgical tracker assembly including a tracker body defining an internal chamber is disclosed. The method also includes applying a sterilant to the surgical tracker assembly as part of the sterilization process and allowing at least a portion of the sterilant to flow through at least one channel into the internal chamber and contact the PCB. The method also includes draining the sterilant from within the internal chamber through at least one channel of the tracker body after completion of the sterilization process.

[0011] According to a seventh aspect, a method of manufacturing a surgical tracker assembly is disclosed that includes a tracker body and a printed circuit board (PCB) supporting a plurality of tracking markers. The method also includes forming a tracker body with an internal chamber, where a plurality of openings extend through the tracker body into the internal chamber and where at least one channel extends through the tracker body into the internal chamber. The method also includes applying a coating to the PCB to protect the PCB from fluids during sterilization of the surgical tracker assembly. The method also includes placing the PCB within the internal chamber of the tracker body such that the tracking markers are visible through the openings and such that fluids can access the PCB through the at least one channel during sterilization.

[0012] According to an eighth aspect, a method of activating a surgical tracker is disclosed. The method may include connecting a battery assembly to the surgical tracker. The method also includes placing the battery assembly in a first position in the battery opening, where a first battery contact of the battery assembly engages the first contact and a second battery contact of the battery assembly is disengaged from the second contact, thereby forming an open circuit between the battery assembly and the PCB. The method also includes rotating the battery assembly from the first position to a second position while placed in the battery opening, where the first battery contact of the battery assembly engages the first contact and the second battery contact of the battery assembly engages the second contact, thereby forming a closed circuit between the battery assembly and the PCB.

[0013] According to a ninth aspect, there is provided a battery assembly configured to couple to a battery opening of a surgical tracker. The battery assembly is annular and includes a body defining an exterior surface and an interior chamber configured to receive a battery. Two electrical contacts are coupled to the battery within the interior chamber. A first electrical contact and a second electrical contact extend through the exterior surface of the body such that they are exposed. The first electrical contact is located at a distal end of the body. The second electrical contact is located on a side of the body. The exterior surface includes one or more channels that guide the electrical contact of the surgical tracker into engagement with the second electrical contact in response to rotation of the battery assembly within the battery opening of the surgical tracker.

[0014] According to a tenth aspect, there is provided an adapter for mounting a tracker to a surgical instrument for use with a surgical navigation system for tracking a pose of the surgical instrument.

[0015] Any of the above aspects may be utilized individually or in combination.

[0016] Any of the above aspects may be utilized in any of the following embodiments.

[0017] In some implementations, the tracker body may define at least three tracker body arms, each of which may define at least one opening formed in the tracker body. In some implementations, at least one channel is formed in each tracker body arm of the tracker body. The tracker may be a tool tracker, an anatomical structure tracker, a manipulator tracker or base tracker, an end effector tracker, a pointer tracker, a handheld robotic cutting tool tracker, an imaging device tracker, a limb holder tracker, a surgical table tracker, a head mounted device tracker, etc.

[0018] In some embodiments, the PCB and the tracker body may be configured to have a similar shape. This may include being formed in the shape of a triangle, a square, a rectangle, or other similar polygon. The PCB and the tracker body may also include less conventional shapes, such as an x-shape, a T-shape, etc. In some embodiments, each of the PCB arms is configured to support one of the markers and / or each of the PCB arms is positioned within the tracker body such that each marker is visible through one of a number of openings formed in the tracker body. In some embodiments, the PCB is sterilizable. This may be accomplished by applying a protective coating to the PCB. One type of coating that may be applied to the PCB is a parylene coating. In some embodiments, the PCB includes an infrared (IR) communication receiver. In some embodiments, the PCB may further include a line of sight (LOS) indicator configured to be controlled to indicate the presence and / or absence of line of sight communication from any one or more of the markers to a camera of the surgical navigation system.

[0019] In some embodiments, the tracker body further defines a battery opening configured to receive a battery assembly, the battery being removably coupleable to the tracker body through the battery opening. The first electrical contact and / or the second electrical contact may be disposed in the battery opening and connected to the PCB, the first contact and the second contact configured to engage opposing battery contacts of the battery assembly to form an electrical connection between the battery assembly and the PCB when the battery assembly is disposed in the battery opening. In some embodiments, the battery assembly may be a battery module switch. In some implementations, the battery assembly may provide a seal for the battery opening upon installation. In some embodiments, the battery assembly is a disposable, single-use component.

[0020] According to an eleventh aspect, a sterilizable printed circuit board assembly (PCBA) is provided. The sterilizable printed circuit board assembly includes a printed circuit board (PCB), the substrate may include layers including a first outer layer, a second outer layer, and one or more inner layers disposed between the first outer layer and the second outer layer. The assembly may also include a via-in-pad formed in the PCB substrate and may include a via hole extending through at least one of the layers, the via hole including a first end terminating at one of the inner layers and a second end terminating at or beyond one of the outer layers, and the via-in-pad may include a plating sealing the via hole at the second end. The assembly also includes a sterilization-resistant parylene coating disposed in direct contact with one or both of the first outer layer and the second outer layer.

[0021] According to a twelfth aspect, there is provided a sterilizable surgical or medical device including a housing defining an internal chamber and an opening defined in an exterior surface of the housing and in fluid communication with the internal chamber, the opening being configured to allow fluid to pass into and out of the internal chamber. The device may also include a sterilizable printed circuit board assembly (PCBA) disposed within the interior chamber of the housing, the layers including a first outer layer, a second outer layer, and one or more inner layers disposed between the first outer layer and the second outer layer; a printed circuit board (PCB) substrate; a via-in-pad formed in the PCB substrate and including a via hole extending through at least two of the layers, the via hole may include a first end terminating at one of the inner layers and a second end terminating at or beyond one of the outer layers, the via-in-pad may include plating that seals the via hole at the second end; an electronic or electrical component electrically connected to the via-in-pad and configured to facilitate operation of the surgical or medical device; and a parylene coating that is sterilizable and disposed in direct contact with one or both of the outer layers and in direct contact with at least a portion of the electronic or electrical component.

[0022] According to a thirteenth aspect, there is provided a sterilizable tracking device comprising: an opening defined in an exterior surface of the tracker body and in communication with a channel extending through the tracker body and into the internal chamber, the opening and the channel configured to allow sterile fluid to pass into and out of the internal chamber; The device may also include a sterilizable printed circuit board assembly (PCBA) disposed within an interior chamber of the tracker body, the layers including a first outer layer, a second outer layer, and one or more inner layers disposed between the first outer layer and the second outer layer, a printed circuit board (PCB) substrate, a via-in-pad formed in the PCB substrate and including a via hole extending through at least two of the layers, the via hole may include a first end terminating at one of the inner layers and a second end terminating at or beyond one of the outer layers, the via-in-pad may include plating that seals the via hole at the second end, a tracking marker electrically connected to the via-in-pad, and a parylene coating that is sterilizable and disposed in direct contact with one or both of the outer layers and in direct contact with at least a portion of the tracking marker.

[0023] According to a fourteenth aspect, a sterilizable printed circuit board assembly (PCBA) is provided. The sterilizable printed circuit board assembly includes a printed circuit board (PCB), the substrate may include layers including a first outer layer, a second outer layer, and one or more inner layers disposed between the first outer layer and the second outer layer. The assembly may also include a via-in-pad formed in the PCB substrate, the via-in-pad may include a via hole extending through at least one of the outer layers, the via-in-pad may include a plating that seals the via hole at a second end. The assembly also includes a conformal coating that is sterilizable and disposed in direct contact with one or both of the first outer layer and the second outer layer.

[0024] In some embodiments, the PCBA or sterilizable surgical / medical device can optionally be configured such that plating seals the via holes such that a solder mask is not typically required to seal the via holes.

[0025] In some embodiments, the PCBA or sterilizable surgical / medical device may be optionally configured such that the parylene coating is the only coating disposed on the PCBA. It is also contemplated that the parylene coating is disposed in direct contact with the first and second outer layers and the plating. The parylene coating may be a conformal coating.

[0026] In some implementations, the PCBA or sterilizable surgical / medical device may be configured to optionally further include a surface cap with a via-in-pad disposed over the plating, and the parylene coating disposed in direct contact with the surface cap. It is also contemplated that the via holes have an inner surface plated with a conductive material and a non-conductive material filling the via holes.

[0027] In some embodiments, the PCBA or sterilizable surgical / medical device may be optionally configured such that the plating is integral and flush with one of the outer layers or disposed on one of the outer layers. The PCBA or sterilizable surgical / medical device may also further include an electronic or electrical component electrically connected to the via-in-pad, with the parylene coating covering at least a portion of the electronic or electrical component.

[0028] In some embodiments, the PCBA or sterilizable surgical / medical device may optionally be configured such that the PCB includes one or more conductive traces disposed on or within an inner layer, and the PCB is designed such that no conductive traces are disposed on the outer surface of the outer layer.

[0029] In some embodiments, the PCBA or sterilizable surgical / medical device may optionally include a solder mask applied directly to a portion of the first and second outer layers surrounding the via-in-pad, and a parylene coating is applied directly to the remaining portions of the first and second outer layers and over the solder mask.

[0030] According to a fifteenth aspect, a method of manufacturing a sterilizable printed circuit board assembly (PCBA) is provided. The method includes assembling a printed circuit board (PCB) substrate including a first outer layer, a second outer layer, and one or more inner layers disposed between the first outer layer and the second outer layer. The method also includes forming a via-in-pad in the PCB substrate having a via hole extending through at least one of the outer layers. The method also includes sealing the via hole at a second end with plating. The method also includes applying a sterilization-resistant parylene coating to the PCBA, whereby the parylene coating is disposed in direct contact with one or both of the outer layers.

[0031] Any of the above embodiments may be combined in part or in whole.

[0032] Other features and advantages of the presently disclosed arrangements will be readily appreciated as the same becomes better understood after reading the following description in conjunction with the accompanying drawings. [Brief description of the drawings]

[0033] [Figure 1] FIG. 2 is a perspective view of a battery assembly for use with a tracker, according to one embodiment. [Diagram 2] 2 is another perspective view of the battery assembly of FIG. 1 showing further features of the battery assembly. [Diagram 3] FIG. 3 is another perspective view of the battery assembly of FIGS. 1 and 2, showing the bottom of the battery assembly. [Figure 4A] 4 is a side view of the battery assembly of FIGS. 1 to 3, showing the battery assembly from a first direction. FIG. [Figure 4B] 4 is a side view of the battery assembly of FIGS. 1 to 3, showing the battery assembly seen from a second direction. FIG. [Diagram 5] FIG. 4C is a top view of the battery assembly of FIGS. 1 to 4B. [Figure 6] 6 is a partially exploded view of the battery assembly of FIGS. 1-5, according to one embodiment, the battery assembly including a housing having a first portion and a second portion configured to at least partially enclose a battery. [Figure 7] FIG. 1 is a perspective view of one embodiment of a tracker including a tracker housing and a tracker mount. [Figure 8] 8 is a side view of the tracker of FIG. 7 showing a first side of the tracker. [Figure 9] FIG. 8 is a side view of the tracker of FIG. 7 showing a second side of the tracker. [Figure 10] FIG. 8 is a top view of the tracker of FIG. 7, where the tracker housing includes an upper portion defining an opening through which a fiducial can be observed. [Figure 11] FIG. 8 is a bottom view of the tracker of FIG. 7, where the tracker housing includes a bottom defining a battery opening for receiving a battery assembly, such as the battery assemblies of FIGS. 1-6. [Figure 12] FIG. 8 is a cross-sectional view of the tracker of FIG. 7, showing the internal components of the tracker when assembled. [Figure 13] 8 is a partial exploded view of the tracker of FIG. 7 showing a housing including a top and a bottom, and a printed circuit board positioned so as to be disposed between the top and bottom of the housing. [Figure 14] FIG. 14 is a perspective view of a partially disassembled tracker assembly including the tracker of FIGS. 7-13 and the battery assembly of FIGS. 1-6. [Figure 15] FIG. 15 is a perspective view of the tracker assembly of FIG. 14 including a battery assembly coupled to the tracker. [Figure 16A] FIG. 14 is a perspective view of the battery assembly of FIGS. 1-6 and the electrical connections disposed in the battery opening of the tracker of FIGS. 7-13, showing the placement of the electrical connections in the battery opening relative to the battery assembly prior to coupling the battery assembly to the tracker. [Figure 16B]16B is a perspective view of the battery assembly of FIG. 16A and electrical connections disposed in the battery opening, showing the placement of the electrical connections in the battery opening relative to the battery assembly in a first stage of coupling the battery assembly to the tracker. [Figure 16C] 16B is a perspective view of the battery assembly of FIG. 16A and electrical connections disposed in the battery opening, showing the placement of the electrical connections in the battery opening relative to the battery assembly during a second stage of coupling the battery assembly to the tracker. [Figure 16D] FIG. 16B is a perspective view of the battery assembly of FIG. 16A and the electrical connections disposed in the battery opening, showing the placement of the electrical connections of the battery opening relative to the battery assembly in the final stage of coupling the battery assembly to the tracker, where the battery assembly is coupled to the tracker to create an electrical connection with the circuit board and activate the tracker. [Figure 17A] FIG. 14 is a perspective view of the tracker of FIGS. 7-13 coupled to a surgical instrument, showing one embodiment for removably coupling a tracker mount of the tracker to a key on a surgical instrument. [Figure 17B] FIG. 14 is a perspective view of the tracker of FIGS. 7-13 coupled to a surgical instrument, showing one embodiment for coupling the tracker directly to a base or housing of the surgical instrument. [Figure 18] FIG. 14 is a perspective view of the tracker of FIGS. 7-13 coupled to a connector assembly including a key for attaching the tracker to the connector assembly. [Figure 19] 1 is a partially exploded view of a tracker configuration, the tracker including a housing having a top and a bottom, and a printed circuit board positioned so as to be disposed between the top and bottom of the housing. [Figure 20] 1 is a perspective view of a first configuration of a printed circuit board including a via-in-pad arrangement for connecting electronic or electrical components to traces disposed between outer surfaces of the printed circuit board; [Figure 21A]21 is a cross-sectional view of the printed circuit board of FIG. 20 showing various via-in-pad arrangements of the printed circuit board for defining connections from electronic or electrical components to traces disposed between the exterior surfaces of the printed circuit board. [Figure 21B] FIG. 21B is an enlarged cross-sectional view of the via-in-pad arrangement of the printed circuit board of FIG. [Figure 21C] FIG. 21B is a further enlarged cross-sectional view of the via-in-pad arrangement of the printed circuit board of FIG. 21A. [Figure 21D] FIG. 21B is an enlarged cross-sectional view of an alternative configuration of a via-in-pad arrangement for the printed circuit board of FIG. 21A. [Figure 22] FIG. 2 is a perspective view of a second configuration of a printed circuit board including a via-in-pad arrangement for connecting electronic or electrical components to traces disposed between outer surfaces of the printed circuit board. [Figure 23A] 23 is a cross-sectional view of the printed circuit board of FIG. 22 showing various via-in-pad arrangements of the printed circuit board for defining connections from electronic or electrical components to traces disposed between the outer surfaces of the printed circuit board. [Figure 23B] FIG. 23B is an enlarged cross-sectional view of the via-in-pad arrangement of the printed circuit board of FIG. 23A. [Figure 24] 1 is a flow chart illustrating a method of manufacturing a sterilizable printed circuit board assembly (PCBA). [Diagram 25] 13 is a flowchart illustrating a method of installing a battery assembly in a surgical tracker. [Figure 26] FIG. 1 is a flowchart illustrating a method of sterilizing a surgical tracker assembly that includes a tracker body defining an internal chamber, a plurality of openings extending through the tracker body into the internal chamber, at least one channel extending through the tracker body into the internal chamber, and a printed circuit board (PCB) within the internal chamber and configured to support a plurality of tracking markers. [Figure 27]1 is a flowchart illustrating a method of manufacturing a surgical tracker assembly that includes a tracker body and a printed circuit board (PCB) that supports a number of tracking markers. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] It will be understood that one or more of the configurations shown throughout the figures may have certain components, structural features, and / or assemblies omitted, shown diagrammatically, and / or shown in phantom lines for purposes of illustration.

[0035] I. Surgical Tracker Assembly The present disclosure describes trackers that may be sterilizable such that a single tracker may be used multiple times. To accomplish this, the tracker and / or tracker assembly may include features that aid in the sterilization process. The tracker assembly may be adapted to allow a sterilizing agent utilized in the sterilization process to reach all surfaces of the tracker assembly. Additionally, sensitive electrical or electronic components of the tracker assembly may be treated with an additive or coating to prevent damage when exposed to a sterilizing agent. It is further contemplated that the tracker assembly may include a removable and / or replaceable battery assembly. In addition to powering the electronic components of the tracker assembly, the battery assembly may be configured to activate and / or deactivate the tracker assembly. Other advantages will become apparent as various features of the tracker assembly are described in more detail below.

[0036] Referring now to the figures, where like numerals indicate like or corresponding parts throughout the several views, an embodiment of a surgical tracker assembly 1 is provided. The surgical tracker assembly 1 comprises a surgical tracker 30 (shown in FIGS. 7-13) and a battery assembly 10 (shown in FIGS. 1-6) for use with the surgical tracker 30. The surgical tracker assembly 1 is configured to couple to or is affixed to a surgical object to be tracked. The surgical tracker assembly 1 can be used to track any surgical object, such as a surgical instrument, a navigation pointer or digitizer, a patient's anatomy, a robotic manipulator arm, a robotic manipulator end effector, a robotic manipulator base or cart, a handheld tool, an imaging device or gantry, a limb holder, a surgical table, a head mounted device, etc. The tracker assembly 1 may be utilized to track any object in the surgical system described in U.S. Patent No. 9,119,655, entitled "Surgical Manipulator Capable of Controlling a Surgical Instrument in Multiple Modes," the entire contents of which are incorporated herein by reference. Each of the components of the surgical tracker assembly 1 introduced above are described in more detail below.

[0037] A. Removable Battery Assembly Embodiments 1-6, the battery assembly 10 may include a housing 12, 14 comprised of a first portion 12 and a second portion 14. The first portion 12 and the second portion 14 collectively define a void 15A, 15B (best shown in FIG. 6) for receiving and housing a battery 16 or similar power source. The first portion 12 and the second portion 14 may be formed from a plastic or similar polymeric material. The material may be selected from a group of polymers capable of providing insulating properties that essentially prevent the battery from making electrical connections other than through designated openings 17, 19 (described below). Alternatively, it is contemplated that all or a limited portion of the first portion 12 and the second portion 14 may be formed from steel, carbon, titanium, or the like material capable of serving as a conductive surface between the battery 16 and the external electrical contacts 45. In another embodiment, the entire housing of the battery assembly 10 may be integrally formed from a single, unitary material.

[0038] The first portion 12 and the second portion 14 may be separable from one another to allow the battery 16 to be inserted and / or installed between the two portions 12, 14. The first portion 12 and the second portion 14 of the battery assembly 10 may include complementary mating features 24, 26 to allow the first portion 12 and the second portion 14 to be removably mated to one another. For example, as best shown in FIG. 6, the first portion 12 and the second portion 14 may include complementary mating features 24, 26 configured to create a snap fit or press fit. This may include one of the first portion 12 or the second portion 14 defining a mating feature 24, 26 that includes a recess, and the other of the first portion 12 and the second portion 14 defining a complementary mating feature 24, 26 that includes a protrusion or detent configured to be inserted into the recess when the first portion 12 and the second portion 14 are mated to one another. The recesses and / or protrusions may be arranged annularly around the respective first and second portions 12, 14. Alternatively, the complementary mating features 24, 26 may include one or more separate features, such as an arrangement of recesses formed as indentations and corresponding protrusions / detents in the opposing portions 12, 14. The first and second portions 12, 14 may also include complementary mating features 24, 26 that include threaded or interlocking configurations that engage and releasably couple the first and second portions 12, 14 by rotating one of the first and second portions 12, 14 relative to the other. For example, the mating features 24, 26 of the first and second portions 12, 14 may comprise mutual threaded portions that are configured to rotationally engage with one another to couple the first and second portions 12, 14 to one another. Alternatively, the mating features 24, 26 of the first and second portions 12, 14 may comprise groove(s) and complementary detent(s) disposed on the first and second portions 12, 14 and configured to couple the first and second portions 12 with a quarter turn or similar tightening procedure. The second portion 14 may include a number of tabs extending from a surface thereof to allow a user to grip and easily rotate the second portion 14.

[0039] The first portion 12 may define a first opening 17 and / or a second opening 19A, 19B. The first opening 17 and / or the second opening 19A, 19B may be disposed on the first portion 12 and configured to provide access to the battery contacts 21A, 21B on the battery 16 from outside the housing 12, 14. For example, the first opening 17 may be defined on a distal (top) surface of the first portion 12 to provide access to the first battery contact 21A on the battery 10. The second openings 19A, 19B may be defined on a side surface of the first portion 12 to provide access to the second electrical contacts 21B on the battery 10. It is further contemplated that the first portion may define two or more second openings 19A, 19B disposed on a side surface of the first portion 12. For example, as shown in FIGS. 1-6, the first portion 12 can be configured to define a pair of second openings 19A, 19B on opposing sides of the first portion 12. As shown in FIG.

[0040] The first portion 12 may also be shaped and / or configured to define features for removably coupling the battery assembly 10 to the tracker 30. For example, the first portion 12 may define one or more vertical channels 18A, 18B or chamfers for receiving and / or orienting the battery assembly 10 relative to complementary features of the tracker 30. The first portion 12 may further define lateral channels 20A, 20B connecting and / or communicating with the vertical channels 18A, 18B. The lateral channels 20A, 20B may be configured to receive complementary features of the tracker 30 and allow rotation of the battery assembly 10 relative to the tracker 30. The vertical channels 18A, 18B and / or the lateral channels 20A, 20B may be further configured to position complementary features on the tracker relative to at least one of the second opening(s) 19A, 19B to form an electrical connection between the battery 16 and the tracker 30. For example, the vertical channels 18A, 18B and / or the lateral channels 20A, 20B may define a path to guide and / or position the electrical connector 45 of the tracker 30 within the openings 17, 19A, 19B and relative to the battery contacts 21A, 21B on the battery 16. For example, the vertical channels 18A, 18B of the battery housings 12, 14 may receive the electrical connector 45 of the tracker 30 and direct the electrical connector 45 into the lateral channels 20A, 20B when the battery assembly 10 is inserted into the tracker 30. The lateral channels 20A, 20B then direct the electrical connector 45 of the tracker 30 into one of the second opening(s) 19A, 19B, and the battery assembly 10 is associated with the tracker 30 such that the electrical connector 45 of the tracker 30 is positioned in contact with one of the battery contacts 21A, 21B of the battery to form an electrical connection between the battery 16 and the tracker 30 through one of the second openings 19A, 19B, as will be described in more detail below.

[0041] In addition to aligning and / or positioning the battery assembly 10 relative to the tracker 30, the vertical channels 18A, 18B and / or the lateral channels 20A, 20B may be configured to couple the battery assembly 10 to the tracker 30. As shown, the vertical channels 18A, 18B may include angled surfaces that lead to the lateral channels 20A, 20B. The angled surfaces of the vertical channels 18A, 18B may enable the use of a component biased against the tracker 30, such as an electrical connector 45, to form a friction fit, a compression fit, an interference fit, or the like, between the vertical channels 18A, 18B and / or the lateral channels 20A, 20B to couple the battery assembly 10 to the tracker 30.

[0042] The battery assembly 10 may further include a mounting member 22 configured to removably secure the battery assembly 10 to a device intended to provide power, such as a tracker 30. For example, the first portion 12 may define one or more mounting members 22A, 22B defined as detents or protrusions, as shown in FIGS. 1-6. The mounting members 22A, 22B may be symmetrical with respect to one another and / or may be mirror opposites to one another. For example, as shown in FIGS. 1-6, the housing 12, 14 includes a first mounting member 22A and a second mounting member 22B arranged in mirror opposites on the first portion 12. Although only the first mounting member 22A and the second mounting member 22B are shown in the figures, it is contemplated that the battery assembly 10 may include only a single mounting member 22 or may include multiple mounting members 22A, 22B symmetrically spaced about the housing 12, 14. The mounting member(s) 22A, 22B defined as detents or protrusions extending from a surface of the first portion 12 of the battery assembly 10 may be configured to cooperate with grooves or channels 46A, 46B on the tracker 30 configured to removably secure the battery assembly 10 to the tracker 30. As described in more detail below, the grooves or channels 46A, 46B on the tracker 30 may be shaped and / or positioned to provide an interlocking coupling mechanism or interference fit with the mounting member(s) 22A, 22B of the battery assembly 10. One advantage of having the mounting members 22A, 22B arranged as mirror opposites or symmetrically about the housings 12, 14 of the battery assembly 10 is that it allows the battery to be easily installed within the tracker 30 in the nearest of multiple orientations relative to the tracker 30. For example, if the battery assembly 10 includes a first mounting member 22A and a second mounting member 22B arranged in mirror-opposed relation, the battery assembly 10 can be mounted within the tracker 30 via the closest orientation of either of the two orientations.The mounting members 22A, 22B may be utilized as the primary means of coupling the battery assembly 10 to the tracker 30 and / or in addition to / in combination with the vertical channels 18A, 18B and / or lateral channels 20A, 20B described above.

[0043] The battery assembly 10 may further include a seal 23, such as a gasket or O-ring, configured to provide a seal between the battery assembly 10 and a device (e.g., tracker 30) to which the battery assembly 10 is coupled. As shown in FIGS. 1, 2, and 6, the seal 23 may be disposed on or around an outer edge of a shoulder defined by the first portion 12 and / or the second portion 14. In one configuration, the seal 23 may be a removable gasket, such as an O-ring. As shown in the figures, the seal 23 is a thermoplastic elastomer (TPE) permanently attached to the first portion 12 of the battery assembly. The seal 23 may be attached by chemical and thermal bonding.

[0044] Although the battery assembly 10 is described as being coupleable to the tracker 30, it is also contemplated that the battery assembly 10 described herein may be configured and / or modified to be coupled to any item requiring a removable and / or replaceable power source. For example, the battery assembly 10 may include a battery sized to operate / power a hand tool, such as a surgical instrument 70 including a drill or saw, with the housings 12, 14 configured and adapted to couple to the hand tool 70 to effect an electrical connection.

[0045] B. Surgical Tracker Implementations 7-13, an example of a configuration of the tracker 30 is shown. The tracker 30 may be powered by the battery assembly 10 described above as part of the tracker assembly 1. The tracker 30 may include a tracker body 32, 34 formed from a first body member 32 and a second body member 34. The tracker body 32, 24 includes a first surface 31A, an opposing second surface 31B, and a plurality of side surfaces 33 connecting between the first surface 31A and the second surface 31B. The first body member 32 and the second body member 34 may be formed from a material that is not prone to damage when exposed to a sterilizing agent or when repeatedly subjected to a sterilization process. It is also contemplated that the first body member 32 and the second body member 34 may be formed from a plastic or similar polymeric material, steel, carbon, titanium, or similar material. The body members 32, 34 may also be integrally formed from a single unitary material.

[0046] The tracker body 32, 34 may include any shape, such as a square, a rectangle, an X-shape, a circle, etc. As shown in the figures, the tracker body 32, 34 may be configured in a generally square shape with arms 35A, 35B, 35C, 35D extending outwardly from the tracker body 32, 34. For example, the tracker body 32, 34 may be shaped with an arm 35A, 35B, 35C, 35D extending from each corner. As shown in the figures, the tracker body 32, 34 may include four arms 35A, 35B, 35C, 35D extending outwardly from the tracker body 32, 34, with each arm 35A, 35B, 35C, 35D extending in a different direction from a center of the tracker body 32, 34. Each of the arms 35A, 35B, 35C, 35D can be configured to define an opening 36A, 36B, 36C, 36D. Although not required, each of the openings 36A, 36B, 36C, 36D can be covered by a window or similar coating that allows light to pass through the opening 36A, 36B, 36C, 36D and / or to be visualized through the opening 36A, 36B, 36C, 36D.

[0047] 13, a chamber 37 is defined between the first surface 31A and the second surface 31B of the first body member 32 and the second body member 34. The first body member 32 and / or the second body member 34 may further define one or more channels 39A, 39B, 39C, 39D extending outwardly from the chamber 37. The one or more channels 39A, 39B, 39C, 39D may extend outwardly from the chamber 37 towards one of the outer surfaces 31A, 31B, 33 of the tracker bodies 32, 34. For example, as shown, the channels 39A, 39B, 39C, 39D extend outwardly from the chamber 37 to each of the arms 35A, 35B, 35C, 35D defined by the tracker bodies 32, 34 and extending through the side surfaces 33. Although not shown in the figure, it is further contemplated that channels 39A, 39B, 39C, 39D may extend outwardly from chamber 37 and through either first surface 31A or second surface 31B of tracker bodies 32, 34.

[0048] The exterior surfaces 31A, 31B, 33 of the tracker bodies 32, 34 may further define one or more openings 38, each of which is in fluid communication with one of the one or more channels 39A, 39B, 39C, 39D. The openings 38, in conjunction with the channels 39A, 39B, 39C, 39D, form pathways to / from and through the chamber 37 of the tracker bodies 32, 34 to allow the sterilant to pass through and into the chamber 37. The channels 39A, 39B, 39C, 39D and the opening(s) 38 also function as a drain to allow any debris, sterilant, etc., that may enter the channels 39A, 39B, 39C, 39D and / or the chamber 37 to exit the tracker bodies 32, 34. As shown in the figures, the second body 34 of the tracker bodies 32, 34 defines at least one opening 38. Alternatively, it is contemplated that the opening may be defined by the first body 32 of the tracker bodies 32, 34. Additionally, while the opening 38 is shown as two openings 38 defined near a corner(s) of the tracker bodies 32, 34 and in communication with the channels 39A, 39B, 39C, 39D, it is further contemplated that there may be only one opening defined in the first body 32 and / or the second body 34 of the tracker body 30 near a corner(s) of the tracker bodies 32, 34. Although not shown in the figures, it is further contemplated that one or more channels 39A, 39B, 39C, 39D may extend from the chamber 37 toward any side or exterior surface of the tracker bodies 32, 34, and an opening may be defined in the side or exterior surface of the tracker bodies 32, 34 in fluid communication with each of the one or more channels 39A, 39B, 39C, 39D.

[0049] The tracker 30 may further include a printed circuit board (PCB) 50. The PCB 50 may be shaped to correspond to the shape of the chambers 37 and channels 39A, 39B, 39C, 39D defined by the tracker bodies 32, 34. For example, assuming that the chambers 37 and channels 39A, 39B, 39C, 39D defined by the tracker bodies 32, 34 are arranged in an X-shape, the PCB 50 may be configured to have a shape that matches the X-shape (e.g., including legs 42A, 42B, 42C, 42D that correspond to the channels 39A, 39B, 39C, 39D formed in the tracker bodies 32, 34). The PCB 50 may include a central portion and a plurality of legs 42A, 42B, 42C, 42D extending from the central portion of the PCB 50. Although the tracker 30 is illustrated as having a generally X-shaped PCB 50, it is contemplated that the PCB 50 may be formed in any number of suitable shapes, such as a square, rectangle, disk, triangle, plate, circle, sphere, trapezoidal cube, etc., that correspond to and / or fit within the shape of the chamber 37 and channels 39A, 39B, 39C, 39D defined by the tracker bodies 32, 34.

[0050] The PCB may further include at least one marker 52A, 52B, 52C, 52D, which may also be referred to as a fiducial or tracking element. The PCB 50 may include traces connecting the markers 52A, 52B, 52C, 52D, a control circuit (not shown), and an electrical connection 45 for forming an electrical connection with the battery 16. The markers 52A, 52B, 52C, 52D may be configured as light sources or reflective markers 52A, 52B, 52C, 52D. The markers 52A, 52B, 52C, 52D may be coupled to the PCB 50 in a unique pattern or arrangement that is identifiable to a navigation system (not shown). For example, as shown in FIG. 13, the markers 52A, 52B, 52C, 52D are disposed on each of the legs 42A, 42B, 42C, 42D of the PCB 50. The markers 52A, 52B, 52C, 52D may be positioned on the PCB 50 such that each of the markers 52A, 52B, 52C, 52D is visible through one of the openings 36A, 36B, 36C, 36D defined in the tracker body 32, 34. For example, as shown in Figure 13, the markers 52A, 52B, 52C, 52D are disposed on the PCB legs 42A, 42B, 42C, 42D such that when the tracker body 32, 34 is assembled to the PCB disposed in the chamber 37, the markers 52A, 52B, 52C, 52D are positioned such that they are visible through the openings 36A, 36B, 36C, 36D. In the example of a PCB 50 that includes markers 52A, 52B, 52C, 52D as light sources such as LEDs, the tracker 30 may also include the above-mentioned battery assembly 10 coupled to the tracker 30. For example, as shown in Figures 14 and 15, the battery assembly 10 may be coupled to the underside of the tracker 30 and electrically connected to each of the markers 52A, 52B, 52C, 52D of the PCB 50. Some implementations of LED tracking markers are shown and described in U.S. Patent Application Publication No. 2019 / 0321108 and International Application No. PCT / IB2020 / 060187, both of which are incorporated herein by reference.

[0051] Thus, the markers 52A, 52B, 52C, 52D of the PCB 50 described above may be arranged in a predefined pattern on the PCB 50 and positioned such that the pattern is visible through 36A, 36B, 36C, 36D to be recognized by a navigation system for tracking a surgical object or surgical instrument 70 associated with the tracker 30. Each marker 52A, 52B, 52C, 52D may be a light emitting diode (LED), more specifically an infrared LED (IR-LED) configured to emit light of a wavelength corresponding to a range of wavelengths detectable by a camera unit of the navigation system.

[0052] With reference to Figures 7-13, examples of tracker 30 configurations are shown. As described above, a tracker 30 including one or more markers 52A, 52B, 52C, 52D may be coupled to a surgical object to enable a navigation system to determine the position and / or orientation of the object during a surgical procedure. The markers 52A, 52B, 52C, 52D may be active light sources (e.g., LEDs) driven by electrical current in a predefined pattern, and the navigation system may be configured to detect the orientation of the tracker 30, and accordingly, the orientation of the surgical object, by detecting optical signals received from the markers 52A, 52B, 52C, 52D and matching the detected optical signals with a predefined pattern. While the tracker 30 described herein may be sterilizable and reusable, it is also contemplated that the tracker 30 may be a disposable tracker. An embodiment of a disposable tracker is shown and described in International Application No. PCT / IB2020 / 059064, which is incorporated herein by reference.

[0053] The PCB 50 may be further configured to withstand exposure to a sterilant and / or sterilization process. Based on the design of the tracker bodies 32, 34 being configured to allow the sterilant to flow into and / or contact all surfaces of the tracker bodies 32, 34, the PCB 50 will likely be exposed to the sterilant when the tracker 30 undergoes a sterilization process. To prevent damage to the PCB 50 from the sterilant and / or sterilization process, the exterior surface(s) of the PCB 50 may be protected by applying a conformal coating 520, which forms a barrier on the PCB 50 to prevent ingress of debris and / or fluids. An exemplary conformal coating may include a parylene film applied to the assembled PCB 50. This may include the application of a parylene film and / or parylene coating applied to the legs 42A, 42B, 42C, 42D, the markers 52A, 52B, 52C, 52D, and / or other components of the PCB 50 during manufacturing.

[0054] As mentioned above, the tracker 30 may be configured to undergo a sterilization process to allow for repeated use of a single tracer 30. A method of sterilizing the surgical tracker 30 may include applying a sterilant to the surgical tracker 30 as part of the sterilization process and allowing at least a portion of the sterilant to flow through the channel 39, into the internal chamber 37 and contact the PCB 50. The method may further include evacuating the sterilant from within the internal chamber 37 through the channel 39 and / or openings 38 defined by the tracker bodies 32, 34 after the sterilization process is completed.

[0055] In some configurations, the tracker 30 may further comprise circuitry for a status indicator 40 electrically coupled to at least one of the markers 52A, 52B, 52C, 52D, the battery 16, and / or the PCB 50. In one embodiment, the status indicator 40 may include an LED that emits visible light (i.e., non-infrared light) so that a surgeon can easily see the status of the tracker 30. The status may relate to the tracker 30 functioning properly or malfunctioning. For example, the status indicator 40 may emit a visible light to indicate when the tracker 30 is operating correctly and / or when the markers 52A, 52B, 52C, 52D are within the field of view of the navigation system (line of sight established). Alternatively, the status indicator 40 may be configured to emit a visible light to indicate when the tracker 30 is not operating correctly and / or when one or more of the markers 52A, 52B, 52C, 52D are not within the field of view of the navigation system (line of sight lost). The status indicator 40 may also be configured to provide additional diagnostic or operational information to the surgeon, such as the remaining battery capacity of the battery assembly 10. For example, the status indicator 40 may flash or blink when the voltage of the battery 16 corresponds to a first level, and the status indicator 40 may be off when the voltage of the battery 16 corresponds to a second level. The status indicator 40 may further be implemented with multiple LEDs, or an LED that can illuminate in multiple colors. If multiple LEDs are used, the voltage level of the battery 16 may correspond to the number of LEDs that are illuminated simultaneously. If a multi-color LED is used, the color may correspond to the voltage level of the battery 16. Any of the other statuses may be communicated to the status indicator 40.

[0056] C. Connecting the Battery Assembly to the Tracker 14 and 15, the tracker 30 may also include a battery mount 44 for mounting the battery assembly 10 to the tracker 30. The battery mount 44 may be configured to connect and / or secure the battery assembly 10 to the tracker body 32, 34 for the purpose of powering the electrical components of the tracker 30, such as the markers 52A, 52B, 52C, 52D. For example, as shown in FIGS. 14 and 15, the battery mount 44 may be disposed directly on the second surface 31B of the second body member 34, which may also be referred to as the bottom or underside, of the tracker body 32, 34 of the tracker 30. Thus, when secured to the battery mount 44, the battery assembly 10 extends outwardly from the second surface 31B of the second body member 34. This arrangement may prevent battery assembly 10 from blocking or interfering with the optical signals emitted by markers 52A, 52B, 52C, 52D by markers 52A, 52B, 52C, 52D being disposed on the opposing first surface 31 A. Although battery mount 44 is shown in the figures as being disposed on second surface 31B of second body member 34, it is also contemplated that battery mount 44 may be disposed on first surface 31A of first body member 32, such as when a navigation system views tracker 30 from an angle that is not affected by battery assembly 10.

[0057] The battery mount 44 defines an opening 48. The opening 48 may be sized and configured to receive the battery assembly 10 described above. For example, the inner diameter of the opening 48 may be sized and / or shaped to receive the first portion 12 of the battery housing 12, 14. The inner surface of the opening 48 may also include grooves or channels 46A, 46B. For example, as shown in FIG. 11, the inner surface of the opening 48 defines channels 46A, 46B positioned opposite one another. Although two channels 46A, 46B are shown in the figures, it is contemplated that the opening 48 may be configured to define only a single channel 46A, 46B, or may be similarly configured to define more than two channels 46A, 46B, 46x.

[0058] The channel(s) 46A, 46B may be sized and shaped to provide for removable coupling of the battery assembly 10 to the tracker 30 via the battery mount 44. For example, the channel(s) 46A, 46B may be positioned within the opening 48 and configured to receive the mounting member(s) 22A, 22B, which may be defined as detents or protrusions extending from an outer surface of the first portion 12 of the battery assembly 10, as described above. The channel(s) 46A, 46B may be shaped to create an interlocking and frictional fit with the mounting member(s) 22A, 22B of the battery assembly 10. For example, the channel(s) 46A, 46B may have an L-shaped configuration, such that when the battery assembly 10 is inserted into the opening 48 of the battery mount 44, the mounting member(s) 22A, 22B of the battery assembly 10 may slide along the channel(s) 46A, 46B and then, once fully inserted, may be rotated or twisted such that the channel(s) 46A, 46B interlock with the mounting member(s) 22A, 22B of the battery assembly 10 to prevent the battery assembly from sliding out.

[0059] The battery mount 44 may further include two or more terminals defining electrical contacts 45A, 45B for engaging the battery 16 of the battery assembly 10 when the battery assembly 10 is inserted into the battery mount 44. Specifically, the electrical contacts 45A, 45B may be configured to transfer electrical energy between the battery 16 disposed in the battery mount 44 and the PCB 50, which is connected to each of the elements of the tracker 30, such as the markers 52A, 52B, 52C, 52D, that require a power source for operation. Several implementations of battery-powered LED tracking markers 52A, 52B, 52C, 52D are shown and described in U.S. Patent Application Publication No. 2019 / 0321108 and International Application No. PCT / IB2020 / 060187, both of which are incorporated herein by reference.

[0060] The electrical contacts 45A, 45B may be sized, shaped, and / or configured to cooperate with the vertical channels 18A, 18B and / or the lateral channels 20A, 20B of the battery assembly 10 described above. As shown in the figures, the tracker 30 may include a first electrical contact 45A and a second electrical contact 45B. The first electrical contact 45A may be configured as a biased or spring-loaded contact configured to be compressible when engaged by the first battery contact 21A of the battery assembly 10. For example, as shown in FIGS. 11 and 16A-16D, the first electrical contact 45A may be configured as a coil spring. Alternatively, the first electrical contact 45A may also be configured as a leaf spring, coil spring, or the like that can provide a resistive force when engaged by the first battery contact 21A of the battery assembly 10 for the purpose of maintaining contact between the first battery contact 21A and the first electrical contact 45A when the battery assembly is coupled to the tracker 30.

[0061] The second electrical contact 45A may be configured to engage and / or interact with at least one of the vertical channels 18A, 18B and / or the lateral channels 20A, 20B. As described above, the vertical channels 18A, 18B may include angled surfaces that may be configured to initiate contact with the second electrical contact 45B. Thus, the second electrical contact 45B may be configured as a biased contact. In operation, as the battery assembly 10 is inserted into the tracker opening 48, the angled surfaces of the vertical channels 18A, 18B may initiate contact with the second electrical contact 45B. As the battery assembly 10 is inserted further into the tracker 30, the second electrical contact 45B becomes compressed as it moves along the angled surfaces of the vertical channels 18A, 18B. In addition to the biasing force helping to ensure contact between the second electrical contact 45B and the battery assembly 10, the biasing force of the second electrical contact 45B can also be configured to create a frictional fit between the battery assembly 10 and the tracker 30 when they are coupled together. The vertical channels 18A, 18B guide the second electrical contact 45B into the lateral channels 20A, 20B as the battery assembly is inserted further into the opening 48. When inserted to its maximum depth, the lateral channels 20A, 20B can be configured to guide the second electrical contact 45B into one of the second opening(s) 19A, 19B of the battery housings 12, 14 and thus into the second battery contact 21B. For example, when the battery assembly 10 is inserted into the opening 48 of the battery mount 44 and the mounting member(s) 22A, 22B of the battery assembly 10 move along the channel(s) 46A, 46B of the battery mount to couple the battery assembly 10 to the battery mount 44, the vertical channels 18A, 18B and / or the horizontal channels 20A, 20B may be configured to position and / or insert the electrical contacts 45A, 45B within the first opening and second opening(s) 17, 19A, 19B of the battery housing 12 to form an electrical connection between the electrical contacts 45A, 45B of the battery mount 44 and the battery contacts 21A, 21B of the battery 16.This may be accomplished by engaging the first electrical contact 45A with the first battery contact 21A and the second electrical contact 45B with the second battery contact 21B to define an electrical circuit between the battery 16 and the PCB 50, and thus between components of the tracker 30 that require power for operation. The step of engaging the first electrical contact 45A with the first battery contact 21A and the second electrical contact 45B with the second battery contact 21B to form an electrical circuit between the battery 16 and the PCB 50 may also function as a selection switch for activating the PCB 50, and more broadly, the tracker 30. Forming a connection between the first electrical contact 45A and the first battery contact 21A, and between the second electrical contact 45B and the second battery contact 21B may be configured to close a circuit, allowing electricity to flow from the battery 16 to the components of the tracker 30. Alternatively, removing the battery assembly 10 from the tracker 30 disconnects the first electrical contact 45A from the first battery contact 21A and engages the second electrical contact 45B with the second battery contact 21B, opening the circuit between the battery 16 and the PCB 50 and rendering the electrical components of the tracker 30 inactive.

[0062] When the battery assembly 10 is coupled to the tracker 30, the seal 23 of the battery assembly 10 may form an airtight seal between the battery assembly 10 and the tracker 30. This may prevent fluid and / or debris from entering the opening 48 when the battery assembly 10 is coupled to the tracker 30. Fluid or debris inside the opening 48 may interfere with the electrical connection between the battery 16 and the electrical contact(s) 45A, 45B of the tracker 30.

[0063] 16A-16D illustrate the positioning of the battery assembly 10 relative to the electrical contacts 45A, 45B of the tracker mount 44 to form an electrical connection between the electrical contacts 45A, 45B of the battery mount 44 and the battery contacts 21A, 21B on the battery 16. For ease of illustration, portions of the tracker mount 44 are not shown. FIG. 16A illustrates the position of the electrical contacts 45A, 45B of the battery mount 44 relative to the battery contacts 21A, 21B on the battery 16 prior to full insertion of the battery assembly 10 into the opening 48 of the battery mount 44 on the tracker 30. In this configuration, the electrical contacts 45A, 45B are fully extended (i.e., not compressed) and separated or disengaged from the battery contacts 21A, 21B, leaving the circuit open and no power being provided from the battery 16 to the tracker assembly 30.

[0064] 16B shows the position of the electrical contacts 45A, 45B of the battery mount 44 relative to the battery contacts 21A, 21B on the battery 16 when the battery assembly 10 is initially inserted into the opening 48 of the battery mount 44 on the tracker 30. The battery assembly is rotationally oriented in a first position relative to the tracker 30 such that the mounting member(s) 22A, 22B are aligned with the channel(s) 46A, 46B and the second electrical contact 45B is aligned with one of the vertical channels 18A, 18B. In this configuration, the first electrical contact 45A may or may not engage the first battery contact 21A. At some point during insertion of the battery assembly 10 into the opening 48, the battery 16 contacts / engages the first electrical contact 45A. When the battery 16 engages the first electrical contact 45A, the first electrical contact is compressed as the battery 16 is further inserted, causing the first electrical contact to become partially loaded. The second electrical contact 45B engages an inlet or upper sloped surface of one of the vertical channels 18A, 18B defined in the battery housing 12, 14. The biasing force of the second electrical contact 45B may create a friction fit with the vertical channel 18A, 18B as it moves along the sloped surface, causing the second electrical contact 45B to compress. As shown in FIG. 16B, the second electrical contact 45B is still separated from the second battery contact 21B of the battery 16, the circuit remains open, and no power is provided from the battery 16 to the tracker assembly 30.

[0065] FIG. 16C shows the position of the electrical contacts 45A, 45B of the battery mount 44 relative to the battery contacts 21A, 21B on the battery 16 when the battery assembly 10 is fully inserted into the opening 48 of the battery mount 44 on the tracker 30. The battery assembly 10 remains rotationally oriented in a first position relative to the tracker 30, with the second electrical contact 45B aligned with one of the vertical channels 18A, 18B. In this configuration, the first electrical contact 45A engages and is compressed with the first battery contact 21A. The second electrical contact 45B engages with the bottom of one of the vertical channels 18, but is still isolated from the second battery contact 21B of the battery, so that the circuit remains open and no power is provided from the battery 16 to the tracker assembly 30. The second electrical contact 45B is compressed to apply a force to the battery assembly 10. When the second electrical contact 45B is positioned at the bottom of the vertical channel 18, the second electrical contact 45B is in a position to transition into the lateral channels 20A, 20B defined in the battery housings 12, 14. At this point, the battery assembly 10 is inserted into the opening of the tracker 30 and the seal 23 of the battery assembly 10 engages the tracker 30. The mounting member(s) 22A, 22B engaging the channel(s) 46A, 46B and / or the second electrical contact 45B engaging the vertical channels 18A, 18B may secure the battery assembly 10 within the tracker opening 48. One advantage of this is that the battery assembly 10 may be coupled to the tracker 30 without activating the tracker 30 and / or draining the battery 16 until the tracker 30 is needed.

[0066] FIG. 16D illustrates the position of the electrical contacts 45A, 45B of the battery mount 44 relative to the battery contacts 21A, 21B on the battery 16 when the battery assembly 10 is fully inserted into the opening 48 and rotated rotationally relative to the tracker 30 to a second position. Rotating the battery housings 12, 14 clockwise relative to the tracker 30 transitions the battery assembly 10 from a first position to a second position relative to the tracker 30. This causes the second battery contact 21B to move through the transverse channels 20A, 20B defined in the battery housings 12, 14. When fully inserted and rotated to the second position relative to the tracker, the first electrical contact 45A remains engaged with the first battery contact 21A while the second electrical contact 45B is positioned to engage the second battery contact 21B of the battery 16. In this configuration, a circuit is closed allowing power from the battery 16 to flow to components of the tracker assembly 30 that require power for operation. At this point, the tracker assembly 1, including the tracker 30 and the battery assembly 10, is activated. The above process can be completed in reverse to remove the battery assembly 10 from the tracker 30 and deactivate the tracker assembly 1. In other words, the battery assembly 10 can be rotated counterclockwise from the second position to the first position to deactivate the tracker assembly 1. The battery assembly 10 can remain securely coupled to the tracker mount 40 while in the first position. In this manner, the battery assembly 10 can function as both a power source and a rotatable selection switch. This allows the user to avoid unnecessary drain on the battery 16 when the tracker 30 is not being used, since the tracker 30 will not be activated and / or power will not be drawn from the battery 16 until the battery assembly 10 is rotated from the first position to the second position.

[0067] It is also contemplated that the battery assembly 10, such as the housing 12, 14, may include indicia and symbols configured to identify the battery 16, the battery assembly 10, etc. The indicia may include text, visual identifiers, color coding, bar codes, etc. The indicia may be etched into the housing 12, 14, may be provided on a sticker, or may be attached to the housing 12, 14 in a similar manner. For example, the housing 12, 14, such as the exposed surface of the second portion 14, may include indicia identifying the size and / or power of the battery 16 disposed within the battery housing 12, 14. This may help a user identify which tracker 30 the battery 16 can power. The housing 12, 14 may also include indicia identifying the size and / or shape of the housing 12, 14 to identify which tracker 30 the battery assembly 30 is compatible with. For example, there may be multiple trackers 30 of different sizes, and the indicia may identify which tracker 30 the battery assembly 10 is coupled to. The indicia may also include text or symbols indicating how to couple and / or remove the battery assembly 10 from the tracker 30. For example, the housings 12, 14 may include a curved line with arrows on opposite ends of the line. A first arrow indicates a rotation direction for moving the battery assembly 10 to a first position (i.e., off) and a second arrow indicates a rotation direction for moving the battery assembly 10 to a second position (i.e., on). This may also include an indication of how to remove the battery 16 from the housings 12, 14.

[0068] The tracker bodies 32, 34 may also include textual or graphic indicia. The indicia may be etched into, protrude from, or printed on the surface of the tracker bodies 32, 34. The indicia may indicate how to couple and / or detach the battery assembly 10 from the tracker 30. For example, the indicia on the tracker bodies 32, 34 may represent a first position and a second position (on or off) of the battery assembly 10. This may include a pair of arrows or markings spaced radially around the opening of the tracker body 34 that correspond to similar indicia on the battery assembly 10. The first arrow identifies the first position and the second arrow identifies the second position. When the corresponding marking on the battery assembly 10 is positioned adjacent to the first arrow, the battery assembly 10 is in the first position (i.e., off). Alternatively, when the corresponding marking on the battery assembly 10 is positioned adjacent to the second arrow, the battery assembly 10 is in the second position (i.e., on).

[0069] The separability of the battery assembly 10 from the tracker 30 allows the battery 16 to be replaced and / or recharged. For example, after a medical procedure, the battery assembly 10 can be removed from the battery opening 48 and replaced with a new battery 16. The battery assembly 10 with the new battery 16 can then be reinstalled in the opening 48 of the tracker 30 as described above to activate the tracker assembly 1. Alternatively, the battery assembly 10 may be removed from the battery opening 48 of the tracker, and then a second battery assembly 10 can be installed in the opening 48 of the tracker 30 in the same manner as described above. The removed battery assembly 10 can optionally be discarded, disposed of, or reprocessed. Reprocessing may include replacing the battery 16 of the battery assembly 10. Of note, reprocessing may include recharging the battery 16 of the battery assembly 10.

[0070] As described above, the tracker 30 may include one or more active markers 52A, 52B, 52C, 52D disposed on and driven by the PCB 50 of the tracker 30. Control circuitry of the PCB 50 (or control circuitry coupled to the PCB) may be coupled to the battery assembly 16 to provide power to the markers 52A, 52B, 52C, 52D via the PCB 50. The PCB 50 may be configured to control any operating parameter of the light emitted from the markers 52A, 52B, 52C, 52D, such as by adjusting the current, voltage, or power provided from the battery 16 to the markers 52A, 52B, 52C, 52D. These operating parameters may include transmission power, intensity, firing sequence, wavelength, etc.

[0071] D. Tracker Mount 17A and 17B, the tracker 30 may further include a tracker mount 60 for removably coupling the tracker assembly 1, including the tracker 30 and / or the battery assembly 10, to a surgical object or instrument. The tracker mount 60 may include a preload mechanism 62, such as a button or biasing member, to secure a surgical instrument 70 to the tracker mount. The instrument may include a key 64, the tracker mount 60 configured to receive the key 64, and the preload mechanism 62 configured to engage the key 64 to removably secure the key 64 to the tracker mount.

[0072] FIG. 17A illustrates the surgical tracker 30 and / or surgical tracker assembly 1 coupled to a surgical instrument 70, according to one embodiment. For illustrative purposes, a generally depicted surgical instrument 70 configured for handheld use, such as a pointer, is illustrated in FIGS. 17A and 17B. However, it is further contemplated that the surgical tracker 30 and / or surgical tracker assembly 1 may be used with any suitable type of surgical instrument 70 without departing from the scope of the present disclosure. For example, the surgical tracker assembly 1 may be coupled to a robotic arm, a surgical saw, a drill, a patient, etc. As shown in FIG. 17A, the surgical instrument 70 includes a tracker coupling member 72A. The tracker coupling member 72A may be referred to as a key 64 and may be configured to removably couple with a tracker mount 60 of the surgical tracker assembly 1, which will be described in more detail below.

[0073] It is further contemplated that the surgical tracker assembly 1 and the surgical instrument 70 may be constructed as an integral device, in which case a portion of the surgical instrument 70 forms the tracker coupling member 72B, and the surgical tracker assembly 1 is disposed on the tracker coupling member 72B. For example, the tracker coupling member 72B may be integrally formed with the first body member 32 or the second body member 34 of the tracker bodies 32, 34. Alternatively, the tracker coupling member 72B may be coupled to the tracker bodies 32, 34 by welding, adhesive, epoxy, or similar coupling means.

[0074] In addition to handheld surgical instruments 70 of various types and configurations, embodiments of the tracker assembly 1 may also be used in connection with surgical instruments 70 that can be controlled, guided, positioned, or otherwise manipulated by one or more types of surgical robots. Certain types of surgical robots are disclosed in U.S. Pat. No. 9,119,655, entitled "Surgical Robotic arm Capable of Controlling a Surgical Instrument in Multiple Modes," U.S. Pat. No. 10,456,207, entitled "Systems and Tools for use with Surgical Robotic Manipulators," U.S. Patent Application Publication No. 2019 / 0231447, entitled "End Effectors And Methods For Driving Tools Guided By Surgical Robotic Systems," U.S. Patent Application Publication No. 2016 / 0302871, entitled "Integrated Medical Imaging and Surgical Robotic System," and U.S. Patent Application Publication No. 2020 / 0078097, entitled "Methods and Systems for Robot-Assisted Surgery," the disclosures of each of which are incorporated herein by reference in their entireties.

[0075] It is further contemplated that aspects of the tracker assembly 1 may also be used in conjunction with a connector assembly 66, an embodiment of a connector assembly 66A, 66B including a key 64 for removably mounting the tracker assembly 1 is described in U.S. Pat. No. 10,537,395, entitled "Navigation tracker with kinematic connector assembly," which is incorporated herein by reference in its entirety. With reference to FIG. 18, an embodiment of the connector assembly 66A, 66B may include a preload mechanism 62 for securing the key 64 to the tracker mount 60. The preload mechanism 62 is configured to engage the key 64 with the tracker mount 60 such that the key 64 is kinematically constrained to the tracker mount 60 by six contact points. As shown in one embodiment of FIG. 18, the connector assembly 66A, 66B may be used to couple the tracker 30 to the extension arm in the same relative position throughout a surgical procedure. The connector assemblies 66A, 66B allow the tracker 30 to be disconnected from the extension arm and repeatedly connected to the extension arm or directly to the bone plate 68 without the need to recalibrate the navigation system and / or realign the tracker assembly 1 to the object. Similarly, the tracker 30 and extension arm can be disconnected from and repeatedly connected to the bone plate 68 as a unit without the need to recalibrate the navigation system or realign the tracker assembly 1 to the object. At least one connector assembly 66A, 66B can be used to couple the tracker 30 and / or the bone plate 68 to either end of the extension arm. The bone plate 68 can then be coupled to a patient, bone, or other object tracked by the navigation system.

[0076] In the configuration shown in FIG. 18, the tracker 30 is coupled to a first end of the extension arm using a first connector assembly 66A. The bone plate 68 is coupled to a second end of the extension arm via a second connector assembly 66B. It should be understood that the second connector assembly 66B is generally similar to the first connector assembly 66A, such that components from the first connector assembly 66A are interchangeable with components from the second connector assembly 66B. For example, the tracker 30 may be coupled directly to the bone plate 68 such that the assembly includes only one connector assembly 66A, 66B.

[0077] The tracker assembly 1, the tracker 30, and / or the tracker mount 72 may further include textual or graphical indicia. The indicia may include arrows, text, or other similar markings. The indicia may be configured to assist a user in coupling and / or removing the tracker 30 from the tracker mount and / or connector assembly 66A, 66B. This may include markings to assist with alignment, markings to provide directional indicators, and the like. For example, the tracker assembly 1 and the tracker mount 72 may include markings that indicate how to align the tracker assembly 1 with respect to the tracker mount 72.

[0078] E. Printed Circuit Board Embodiments 19-23, various additional embodiments and / or configurations of printed circuit boards (PCBs) 50, 150 are described.

[0079] 19, a sterilizable surgical device 1, such as a surgical tracker 30 and / or surgical tracker assembly 1, is shown. In the exemplary configuration shown in FIG. 19, the sterilizable surgical tracker 30 may include all of the same features and provide all of the same functionality as the tracker assemblies shown in FIGS. 13-18 and described above. For example, as shown in FIG. 19, the tracker 30 may include a tracker body 32, 34 formed from a first body member 32 and a second body member 34. The tracker body 32, 24 includes a first surface 31A, an opposing second surface 31B, and a number of side surfaces 33 connecting between the first surface 31A and the second surface 31B.

[0080] The first and second body members 32, 34 may be formed from a material that is not susceptible to damage when exposed to a sterilizing agent or when repeatedly subjected to a sterilization process. It is also contemplated that the first and second body members 32, 34 may be formed from a plastic or similar polymeric material, steel, carbon, titanium, or similar material. It is further contemplated that the first and second body members 32, 34 may be formed from any rigid or generally rigid material and then coated with a conformal coating on one or more of the exterior surfaces of the first and second body members 32, 34, the conformal coating being configured to protect the first and second body members 32, 34 from damage when subjected to a sterilization process, such as autoclaving. The conformal coating applied to the surface(s) of the first and second body members 32, 34 may include one or more of the following: epoxy, polyurethane, parylene or parylene polymer, silicone, acrylic, or similar protective coating. The coating may also be referred to as a film, film coating, or film-like layer. For example, a parylene coating may be applied and / or disposed on the first body member 32 and / or the second body member 34 to protect the first body member 32 and the second body member 34 from damage when subjected to a sterilization process. Although the surgical tracker 30 is shown as one exemplary configuration of a sterilizable surgical device 1 to which a conformal coating such as parylene may be applied, it should be understood that the conformal coating may also be applied to other sterilizable surgical devices 1 to protect the device during a sterilization process, as further contemplated. Some examples of sterilizable surgical devices 1 may include drills, surgical handpieces, saws, drivers, saw blades, tracker mounts, surgical instruments, surgical instrument tips or bits, surgical helmets, headpieces, or similar sterilizable devices.

[0081] As noted above, the tracker bodies 32, 34 may have any shape, such as a square, a rectangle, an X-shape, a circle, etc. As shown in the figures, the tracker bodies 32, 34 may be configured in a generally square shape with arms 35A, 35B, 35C, 35D extending outwardly from the tracker bodies 32, 34. Each of the arms 35A, 35B, 35C, 35D may be configured to define an opening 36A, 36B, 36C, 36D. Although not required, each of the openings 36A, 36B, 36C, 36D may be covered by a window or similar coating that allows light to pass through the opening 36A, 36B, 36C, 36D and / or be visualized through the opening 36A, 36B, 36C, 36D.

[0082] 19, a chamber 37 is defined between the first surface 31A and the second surface 31B of the first body member 32 and the second body member 34. The first body member 32 and / or the second body member 34 may further define one or more channels 39A, 39B, 39C, 39D extending outwardly from the chamber 37. The one or more channels 39A, 39B, 39C, 39D may extend outwardly from the chamber 37 towards one of the outer surfaces 31A, 31B, 33 of the tracker bodies 32, 34. Although not shown in the figures, it is further contemplated that the channels 39A, 39B, 39C, 39D may extend outwardly from the chamber 37 and through either the first surface 31A or the second surface 31B of the tracker bodies 32, 34.

[0083] The exterior surfaces 31A, 31B, 33 of the tracker bodies 32, 34 may further define one or more openings 38, each of which is in fluid communication with one of the one or more channels 39A, 39B, 39C, 39D. The openings 38, in conjunction with the channels 39A, 39B, 39C, 39D, form pathways to / from and through the chamber 37 of the tracker bodies 32, 34 to allow the sterilant to pass through and into the chamber 37. The channels 39A, 39B, 39C, 39D and the opening(s) 38 also function as drains to allow any debris, sterilant, etc., that may enter the channels 39A, 39B, 39C, 39D and / or the chamber 37 to exit the tracker bodies 32, 34. While the exemplary configuration of tracker bodies 32, 34 shown in the figures defines two openings 38 in each arm of the second body member 34, it is contemplated that one opening 38 may be defined in each arm of the second body member 34. Alternatively, openings 38 may be formed in the first body member 32 of the tracker bodies 32, 34 and in fluid communication with one of the one or more channels 39A, 39B, 39C, 39D to form a pathway to / from and through chamber 37 of the tracker bodies 32, 34 to allow sterilant to pass through and into chamber 37.

[0084] The tracker 30 may further include a printed circuit board (PCB) 50, 150. The printed circuit may include all of the same features and / or functionality as the described PCB 50. Thus, the components of the PCB 150 shown in Figures 19-23B should be understood to have at least the same features and / or functionality as the above-described PCB 50 having the same base number (the last two digits of the reference number). For example, the markers 152A, 152B, 152C, 152D shown in Figures 19-23B have the same features and functionality as the described markers 52A, 52B, 52C, 52D.

[0085] The PCB 150 may be shaped to correspond to the shape of the chambers 37 and channels 39A, 39B, 39C, 39D defined by the tracker bodies 32, 34. For example, assuming that the chambers 37 and channels 39A, 39B, 39C, 39D defined by the tracker bodies 32, 34 are arranged in an X-shape, the PCB 150 may be configured to have a shape that conforms to the X-shape (e.g., including legs 142A, 142B, 142C, 142D that correspond to the channels 39A, 39B, 39C, 39D formed in the tracker bodies 32, 34). The PCB 150 may include a central portion and a plurality of legs 142A, 142B, 142C, 142D extending from the central portion of the PCB 150. Although the tracker 30 is illustrated as having a generally X-shaped PCB 150, it is contemplated that the PCB 150 may be formed in any number of suitable shapes, such as a square, rectangle, disk, triangle, plate, circle, sphere, trapezoidal cube, etc., that correspond to and / or fit within the shape of the chamber 37 and channels 39A, 39B, 39C, 39D defined by the tracker bodies 32, 34.

[0086] 20-21D, the PCB 150 may be formed from one or more layers 151 from a base or body of the PCB 150. The layers 151 may be stacked, layered, disposed adjacent to one another, or disposed in a similar relationship to one another. With reference to FIGS. 21A and 23A, an exemplary configuration of the PCB may include four layers 151A, 151B, 151C, 151D, including two outer layers 151A, 151B and two inner layers 151C, 151D, which are disposed or sandwiched in a stacked configuration between the two outer layers 151A, 151B. Although the exemplary configuration of the PCB 150 is shown as having two inner layers 151C, 151D disposed between two outer layers 151A, 151B, it is contemplated that the PCB 150 may include any number of inner layers 151C, 151D. For example, the PCB 150 may include three, four, five, or more inner layers 151C, 151D disposed between the two outer layers 151A, 151B.

[0087] As discussed above, the PCB 150 may include traces, also known as circuit trace(s). A trace is generally a conductive track on a printed circuit board that electrically connects components and allows electrical current to flow with little resistance. For example, as discussed above, the trace(s) of the PCB 150 may be disposed on the PCB 150 and configured to connect the markers 152A, 152B, 152C, 152D, the control circuit (not shown), and the electrical connection 45 for forming an electrical connection with the battery 16. The trace(s) may also be disposed and configured to form an electrical connection between one or more electronic or electrical components 180 of the PCB 150. In the configuration of the PCB 150 shown in FIGS. 19-23B, there are no trace(s) disposed on the outer surface of the PCB 150. For example, there are no traces disposed on the outer surface of either of the outer layers 151A, 151B. All traces are disposed between the outer surfaces of the opposing outer layers 151A, 151B. For example, the traces may be disposed on either of the inner layers 151C, 151D. It is further contemplated that the traces may be disposed on an inner surface of the outer layers 151A, 151B, for example, where the outer layers 151A, 151B abut one of the inner layers 151C, 151D. Removing the traces from the outer surface(s) of the PCB 150 may further protect the traces from damage during use, exposure, and / or cleaning, such as when the PCB 150 undergoes a sterilization process.

[0088] The PCB 150 may further include one or more via-in-pad 139 arrangements in / on the PCB 150. The via-in-pad 139 may include an opening or hole 143 defined in one or more layers 151A, 151B, 151C, 151D of the PCB 150. For example, as shown in Figures 21A and 23A, the via-in-pad 139B may include a hole 143B defined by and passing through each of the layers 151A, 151B, 151C, 151D of the PCB 150. In another example, the via-in-pad 139C may include a hole 143C defined by and passing through one of the outer layers 151A (top) and two of the inner layers 151C, 151D of the PCB 150. The via-in-pad 139C may be utilized to connect an electronic or electrical component 180C disposed on the first outer layer 151A to one or more traces disposed between the other two layers 151A, 151B. Alternatively, in another exemplary configuration, the via-in-pad 139C may include a hole 143F defined by and extending through one of the outer layers 151B (bottom) and two of the inner layers 151C, 151D of the PCB 150. The via-in-pad 139F may be utilized to connect an electronic or electrical component 180F disposed on the second outer layer 151B to one or more traces disposed between the other two layers 151A, 151B.

[0089] 21B-21D and 23B, the hole 143 of the via-in-pad 139 defined in at least one of the outer layers 151A, 151B and / or one or more of the inner layers 151C, 151D may be filled and / or plated with one or more materials 147, 149. The material 147, 149 applied and / or disposed in the hole 143 of the via-in-pad 139 may include a conductive material, a non-conductive (electrically insulating) material, or a combination of a conductive material and a non-conductive material. The hole 143 of the via-in-pad 139 may be filled with a single material. It is contemplated that the hole 143 of the via-in-pad 139 may also be filled with multiple materials. For example, as shown in FIGS. 21B-21D, the hole 143 of the via-in-pad 139 may include a first material 147 and a second material 149. A first material 147 may be applied and / or disposed on the inner surface of the hole 143. The first material 147 may be applied and / or disposed on the inner surface of the hole 143 along the entire length of the hole 143. The first material 147 may include a plating, a metal, a polymer, a resin, an epoxy, or a similar material having conductive or non-conductive properties.

[0090] The hole 143 of the via-in-pad 139 may also include a second material 149. The second material 149 may also be disposed within the hole 143 of the via-in-pad 139. As shown in FIG. 21B-D, an exemplary configuration of the via-in-pad 139 includes a first material 147 disposed on an inner surface of the hole 143, the first material 147 having a thickness that defines a cylinder that defines a void along the length of the hole 143, such that the first material 147 does not completely fill the hole 143. The second material 149 may then be applied within the void defined by the first material 147. The second material 149 may include a plating, a metal, a polymer, a resin, an epoxy, or a similar material having conductive or non-conductive properties. In an exemplary configuration of the via-in-pad 139, the first material 147 may include conductive properties and the second material 149 may include non-conductive or insulating properties, with the first material 147 configured to form an electrical connection with one or more traces disposed between the outer layers 151A, 151B of the PCB 150. Alternatively, it is contemplated that the first material 147 may include non-conductive or insulating properties and the second material 149 may include conductive properties, with the second material 149 configured to form an electrical connection with one or more traces disposed between the outer layers 151A, 151B of the PCB 150. Although the figure illustrates the hole 143 of the via-in-pad 139 as being filled with multiple materials, it is also contemplated that the hole 143 of the via-in-pad 139 may be filled with a single material, which has conductive properties for forming an electrical connection with one or more traces disposed between the outer layers 151A, 151B of the PCB 150.

[0091] The via-in-pad 139 may further include a cap 141 disposed over the opening of the hole 143 defined in the outer layers 151A, 151B. The cap may also be referred to and / or described as a plating. The cap 141 covers the opening of the hole 143 of the via-in-pad 139. A cap may be disposed over each opening defined in one of the outer layers 151A, 151B of the PCB 150. For example, as shown in FIGS. 21A-21D, the cap 141 may be disposed on the outer layers 151A, 151B and cover an opening defined on an outer surface of the outer layers 151A, 151B, with a portion of the cap bonded to and / or disposed on the outer surface of the outer layers 151A, 151B. In instances where the hole 143B of the via-in-pad 139B extends completely through the PCB 150, the caps 141B, 141B may be disposed over openings defined in the first outer layer 151A and the second outer layer 151B, respectively.

[0092] The cap 141 is configured to define an electrical connection with the material 147, 149 disposed within the hole 143 of the via-in-pad 139. More specifically, the cap 141 can form an electrical connection with the material 147, 149 within the hole 143 that includes conductive properties, the material 147, 149 comprising conductive properties that form an electrical connection between the cap 141 and one or more traces disposed between the outer layers 151A, 151B of the PCB 150. The cap 141 can also be configured to form an electrical connection with an electronic or electrical component 180 of the PCB 150. For example, as shown in FIGS. 20 to 21D, the electrical component 180 can be coupled and / or electrically connected to the PCB 150 by the via-in-pad 139, more specifically, the electrical component 180 can be connected by the cap 141 of the via-in-pad 139. The cap 141 may be configured to form an electrical connection between the electrical component 180 in the hole 143 of the via-in-pad 139 and the material 147, 149, and thus to form an electrical connection with one or more traces disposed between the outer layers 151A, 151B of the PCB 150. In combination with multiple traces interconnecting the various via-in-pads 139A, 139B, 139C, 139D, 139E, 139F, the multiple via-in-pads 139A, 139B, 139C, 139D, 139E, 139F may be utilized to form connections between multiple electrical components 180A, 180B, 180C, 180D, 180E, 180F of the PCB 150. In an exemplary configuration in which the hole 143B of the via-in-pad 139B extends completely through the PCB 150, the caps 141B, 141E can be disposed over openings defined in each of the first outer layer 151A and the second outer layer 151B, with each of the caps 141B, 141E forming a direct connection between the electrical components 180B, 180E coupled to the respective caps 141B, 141E.

[0093] A protective coating 153 may be applied to the outer surface(s) of the PCB 150, such as at least the outer surface(s) of the outer layers 151A, 151B of the PCB 150. The coating 153 may also be referred to as a film, a film coating, or a film-like layer. The coating 153 applied to the outer surface(s) of the PCB 150 may include one or more of the following conformal coatings: epoxy, polyurethane, parylene or parylene polymer, silicone, acrylic, or similar protective coatings. As shown in FIGS. 21A to 21D, the protective coating 153 may be applied directly to the outer layers 151A, 151B of the PCB 150. The protective coating 153 may also be applied to the via-in-pad(s) 139 of the PCB 150, such as the caps 141 of the via-in-pad(s) 139. The protective coating 153, such as the conformal coatings described above, may also be applied to the electrical components 180 of the PCB 150. 21A-21D, the protective coating 153 can be applied directly to at least the outer surfaces of the outer layers 151A, 151B, the exposed portions of the via-in-pad 139 (cap 141), and the exposed portions of the electrical component 180. In an exemplary configuration, the protective coating 153 can include a conformal coating known as or called a parylene coating 153, where the parylene coating 153 is applied directly to at least the outer surfaces of the outer layers 151A, 151B, the cap 141, and the electrical component 180. In this example, there is no additional solder mask, or other protective coating, applied to the PCB 150 between the outer layers 151A, 151B and the parylene coatings 153A, 153B. The absence of a solder mask and / or other protective coating disposed between the outer layers 151A, 151B and the parylene coatings 153A, 153B provides the advantage of improved adhesion between the outer layers 151A, 151B and the parylene coatings 153A, 153B.Stated another way, applying parylene coating 153 directly to the outer surfaces of at least outer layers 151A, 151B provides the advantage of improved adhesion between outer layers 151A, 151B and parylene coatings 153A, 153B. Applying parylene coating 153 directly to exposed portions of via-in-pad 139 (e.g., cap 141) and electrical component 180 can similarly provide the advantage of improved adhesion between parylene coatings 153A, 153B and via-in-pad 139 (e.g., cap 141) and / or electrical component 180.

[0094] As noted above, there are no traces disposed on the outer surface of the outer layers 151A, 151B of the PCB 150. By moving the traces from the outer surface of the outer layers 151A, 151B to under or between the outer surface(s) of the outer layers 151A, 151B, such as to be disposed on the outer surface of the inner layer(s) 151C, 151D, the parylene coating 153 can be utilized to protect the PCB 150 during use, handling, exposure to chemicals, and / or cleaning / sterilization processes without the need for a solder mask or another protective coating in addition to the parylene coating 153. Other conformal coatings that may be utilized as protective coatings on the PCB 150 include acrylic coatings, polyurethane coatings, silicone coatings, UV cured coatings, or other hybrid conformal coatings.

[0095] While the example configuration above includes only a protective coating 153, such as a parylene coating, on the outer layers 151A, 151B, the exposed portions of the via-in-pad 139 (cap 141), and the exposed portions of the electrical component 180, FIG. 21D illustrates an alternative configuration of the PCB 150 including a second protective coating 157. For example, the second protective coating 157 may be applied to a portion of the outer surface of the outer layers 151A, 151B of the PCB 150 that surrounds the cap 141 of the via-in-pad 139. The first protective coating 153 may then be applied directly to the remaining portions of the PCB 150, the exposed portions of the via-in-pad 139 (cap 141), the exposed portions of the electrical component 180, and the second protective coating 157. An example of a second protective coating is a solder mask. This configuration using a first protective coating and a second protective coating may be advantageous for some very small electrical components 180 with very small pitches where there may be a risk of short-circuiting between the caps 141 of the via-in-pads 139 without the second protective coating, e.g., a solder mask barrier, applied to a small portion of the outer surface of the outer layers 151A, 151B of the PCB 150 surrounding the caps 141 of the via-in-pads 139. In those situations, a thin (approximately 70 μm) solder mask 157 barrier may be applied around the caps 141 of the via-in-pads 139. This small area of ​​the PCB 150 including both the first protective coating 153 and the second protective coating 157 does not pose any problem even if there is no adhesion from the first protective coating 153 (e.g., a parylene coating) to the area with the second protective coating 157 (e.g., a solder mask).

[0096] 22-23B, an example of the PCB 150 described above is shown, illustrating an alternative configuration of the via-in-pad 139 arrangement. The via-in-pad 139 may be configured to include all of the same features and functionality as described above, but at least a portion of the cap 141 of the via-in-pad 139 may be recessed into the outer layers 151A, 151B. As shown in FIGS. 22-23B, the outer layers 151A, 151B of the PCB 150 may define a recess for receiving at least a portion of the cap 141 of the via-in-pad 139. This may allow the top surface of the cap 141 to be mounted flush or nearly flush with the outer surface of the outer layers 151A, 151B of the PCB 150. In that case, the electronic or electrical component 180 may still be disposed on and / or coupled to the cap 141 to form an electrical connection between the electrical component 180 and the via-in-pad 139 and ultimately to the traces of the PCB 150.

[0097] F. Methods of Manufacturing Sterilizable Surgical Devices Referring to FIG. 24, a method of manufacturing a sterilizable printed circuit board assembly (PCBA) 30, 150 is shown. The method includes assembling a printed circuit board (PCB) substrate 150 including a first outer layer, a second outer layer, and one or more inner layers 151C, 151D disposed between the first outer layer 151A and the second outer layer 151B. The method also includes forming a via-in-pad 139 in the PCB substrate 150 having a via hole 143 extending through at least one of the outer layers 151. The method also includes sealing the via hole at the second end with a plating or cap 141. The method also includes applying a sterilization-resistant parylene coating 153 to the PCBA 30, 150, whereby the parylene coating 153 is disposed in direct contact with one or both of the outer layers 151A, 151B.

[0098] The method may also further include applying parylene coating 153 directly to PCBA 150 without applying solder mask 157 to PCBA 150 to enhance adhesion of parylene coating 153 to PCBA 150. This may include applying parylene coating 153 directly to PCBA 150 such that parylene coating 153 is the only coating applied to PCBA 150. This may also include applying parylene coating 153 such that parylene coating 153 is disposed in direct contact with both outer layers 151A, 151B and plating / cap 141.

[0099] The method of manufacturing the sterilizable printed circuit board assembly (PCBA) 30, 150 may also include the steps of disposing a surface cap over the plating and applying a parylene coating in direct contact with the surface cap. As described above, the surface cap may be at least partially disposed on one of the outer surfaces of the outer layers 151A, 151B of the PCB 150.

[0100] The method of manufacturing a sterilizable printed circuit board assembly (PCBA) 30, 150 may also include the steps of forming a via hole 143 such that the inner surface of the via hole is plated with a conductive material 147, 149 and filling the via hole with a non-conductive material 147.

[0101] The method of manufacturing the sterilizable printed circuit board assembly (PCBA) 30, 150 may also include filling the via holes 143 with a conductive material 147, 149.

[0102] The method of manufacturing a sterilizable printed circuit board assembly (PCBA) 30, 150 may also include sealing the via holes at the second end with plating such that the plating is integral and flush with one of the outer layers, or such that the plating is disposed on one of the outer layers.

[0103] The method of manufacturing a sterilizable printed circuit board assembly (PCBA) 30, 150 may also include the steps of attaching electronic or electrical components to the PCBA and electrically connecting the electronic or electrical components to the via-in-pads.

[0104] The method of manufacturing a sterilizable printed circuit board assembly (PCBA) 30, 150 may also include applying a parylene coating such that the parylene coating covers at least a portion of the electronic or electrical component.

[0105] The method of manufacturing a sterilizable printed circuit board assembly (PCBA) 30, 150 may also include the steps of forming one or more conductive traces in or on an inner layer of the PCB and maintaining an outer surface of an outer layer of the PCB free of conductive traces.

[0106] The method of manufacturing a sterilizable printed circuit board assembly (PCBA) 30, 150 may also include applying a solder mask directly to a portion of the first and second outer layers surrounding the via-in-pads, with a parylene coating in direct contact with the remaining portions of the first and second outer layers and applied over the solder mask.

[0107] Additionally, it will be understood that the terms "include," "includes," and "including" have the same meaning as the terms "comprise," "comprises," and "comprising." Additionally, it will be understood that terms such as "first," "second," "third," etc. are used herein to distinguish certain structural features and components for non-limiting exemplary purposes of clarity and consistency.

[0108] The foregoing description has set forth certain configurations. However, the configurations described herein are not exhaustive and are not intended to limit the invention to any particular form. The terminology used is intended to be in the nature of words descriptive rather than limiting. Many modifications and variations are possible in light of the above teachings, and the invention may be practiced otherwise than as specifically described.

Claims

1. A tracker body comprising a first surface, a second surface spaced apart from the first surface and facing the first surface, and a side defined between the first surface and the second surface, wherein the tracker body defines a chamber formed inside the first surface, the second surface, and the side, Multiple openings formed on the first surface of the tracker body, At least one opening formed on the aforementioned side surface, At least one channel formed within the tracker body, wherein the at least one channel extends from the chamber and terminates in one of the at least one openings formed on the side surface of the tracker body, A printed circuit board (PCB) disposed within the chamber of the tracker body, wherein the PCB is configured to support a plurality of markers that can be actively energized through the PCB, and each of the plurality of markers is visible through one of the plurality of openings of the tracker body, A surgical tracker, wherein the tracker body is configured to sterilize the PCB by positioning it within the chamber of the tracker body, and each of the at least one channel and each of the at least one opening formed on the side is configured to allow a sterilization fluid to enter and exit the chamber of the tracker body during sterilization, thereby sterilizing the PCB.

2. The surgical tracker according to claim 1, wherein the tracker body defines at least three tracker body arms.

3. The surgical tracker according to claim 2, wherein each of the tracker body arms defines at least one of the plurality of openings formed on the first surface.

4. The surgical tracker according to claim 2 or 3, wherein the at least one channel comprises a plurality of channels, and one of the plurality of channels is formed within each tracker body arm of the tracker body.

5. The surgical tracker according to claim 4, wherein each tracker body arm has a distal end, and each of the at least one channel formed within each tracker body arm extends from the chamber to the distal end of the tracker body arm.

6. The surgical tracker according to any one of claims 1 to 3, wherein the PCB and the tracker body have similar shapes.

7. The surgical tracker according to any one of claims 1 to 3, wherein the PCB includes a plurality of PCB arms, each of which is configured to support one of the plurality of markers.

8. The surgical tracker according to claim 7, wherein each of the plurality of PCB arms is positioned in one of the at least one channel formed in the tracker body, and each of the plurality of markers is positioned on each of the plurality of PCB arms and occupies one of the plurality of openings formed on the first surface.

9. The surgical tracker according to any one of claims 1 to 3, wherein the PCB is sterilizable.

10. The surgical tracker according to any one of claims 1 to 3, wherein the PCB is protected by a coating, and the coating is a parylene coating.

11. The surgical tracker according to any one of claims 1 to 3, wherein the PCB includes an infrared (IR) communication receiver.

12. The surgical tracker according to any one of claims 1 to 3, wherein the PCB is separate from the marker and comprises an IR LED configured to communicate with a camera of a surgical navigation system.

13. The surgical tracker according to any one of claims 1 to 3, wherein the PCB includes a line-of-sight (LOS) indicator configured to indicate the presence and / or absence of line-of-sight communication from one or more of the markers to a camera of a surgical navigation system.

14. The tracker body further defines a battery opening on the second surface of the tracker body, which is configured to receive a battery assembly. The surgical tracker according to any one of claims 1 to 3, further comprising a battery that can be detachably coupled to the tracker body via the battery opening.

15. The surgical tracker according to claim 14, further comprising a first electrical contact and a second electrical contact disposed in the battery opening and connected to the PCB, wherein the first electrical contact and the second electrical contact are configured to engage with opposing battery contacts of the battery when the battery is disposed in the battery opening, thereby forming an electrical connection between the battery and the PCB.

16. A tracker body comprising a first surface, a second surface spaced apart from the first surface and facing the first surface, and a side surface defined between the first surface and the second surface, Multiple openings defined on the first surface, Internal chamber and At least one opening formed on the aforementioned side surface, At least one channel extending through the tracker body into the internal chamber and defining a path between at least one of the at least one openings and the internal chamber, wherein the at least one channel is configured to allow fluid to enter and exit the internal chamber of the assembled tracker body, The tracker body defines the, A printed circuit board (PCB) located within the internal chamber and configured to support a plurality of tracking markers, wherein each tracking marker is visible through one of the plurality of openings and substantially occupies one of the plurality of openings, A surgical tracker equipped with [specific features / equipment].

17. The tracker body defines the internal chamber, A channel extending through the tracker body into the internal chamber, wherein the channel is configured to allow sterilization fluid to enter and exit the internal chamber, A printed circuit board (PCB) at least partially disposed within the internal chamber, wherein the PCB supports at least one tracking marker, A surgical tracker assembly comprising, The surgical tracker assembly, wherein the PCB is coated with a parylene coating to protect the PCB from the sterilization fluid that enters the internal chamber of the tracker body through the channel during sterilization.

18. A method for sterilizing a surgical tracker assembly comprising a tracker body defining an internal chamber, a plurality of openings extending through the tracker body into the internal chamber, at least one channel extending through the tracker body into the internal chamber, and a printed circuit board (PCB) located within the internal chamber and configured to support a plurality of tracking markers, As part of the sterilization process, a sterilizing agent is applied to the surgical tracker assembly, and at least a portion of the sterilizing agent is allowed to flow through the at least one channel into the internal chamber and come into contact with the PCB. After the completion of the sterilization process, the sterilizing agent is discharged from the internal chamber through at least one channel of the tracker body. The method, including the method described above.

19. A method for manufacturing a surgical tracker assembly, which includes a tracker body and a printed circuit board (PCB) supporting multiple tracking markers, The form of the tracker body having an internal chamber, wherein a plurality of openings extend through the tracker body into the internal chamber, and at least one channel extends through the tracker body into the internal chamber, To protect the PCB from fluids during sterilization of the surgical tracker assembly, a coating is applied to the PCB. The PCB is placed in the internal chamber of the tracker body such that the tracking marker is visible through the opening and the fluid can access the PCB through at least one channel during sterilization. The method, including the method described above.

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