Surgical depth instrument

Abstract

To provide a preferable surgical depth instrument.SOLUTION: A device is disclosed configured to provide a faster and more accurate measurement of depths of holes for placement of bone screws and fastener for bone implant fixation procedures. The device includes a combination of a bone probe for physical examination of a hole drilled in a bone and a depth gauge member for determining a depth of the hole and providing digital measurement of the depth via a display on the instrument and / or via a wireless exchange of measurement data to a remote computing device, such as a tablet or smartphone.SELECTED DRAWING: Figure 34

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of and priority to U.S. Provisional Application No. 62 / 937,530, filed November 19, 2019, U.S. Provisional Application No. 62 / 901,905, filed September 18, 2019, and U.S. Provisional Application No. 62 / 816,536, filed March 11, 2019, the contents of each of which are incorporated herein by reference in their entirety.

[0002] The present disclosure relates generally to medical devices, and more particularly to a measuring instrument for use in bone implant fixation procedures, the measuring instrument including a combination of a bone probe that allows for physical inspection of a hole drilled in bone, and a depth gauge member for determining the depth of the hole and providing a digital measurement of the depth. [Background technology]

[0003] Orthopedics is a medical field concerned with the correction of deformities or dysfunctions of the skeletal system, particularly the limbs, spine, and associated structures such as muscles and ligaments. Some orthopedic surgical procedures require the surgeon to secure a device to one or more bones of a patient. For example, in some procedures, the surgeon may use one or more fasteners, such as bone plates and screws, to span and secure one or more bones or multiple pieces of a single bone. However, other bone-related surgical procedures may not require bone plates and may instead rely solely on the use of one or more screws (e.g., to secure a grafted tendon).

[0004] In such bone-related surgical procedures, an opening is typically drilled into the bone to accommodate the screw before the implant or plate or simply the screw itself can be attached to the bone. When the hole is in place, the surgeon can more easily select the appropriate length screw. However, selecting the appropriate length screw is critical. For example, if the selected screw is too long, the distal end of the screw may pass through the end of the drilled hole and cause damage to the bone and / or protrude completely through the bone, which may have adverse effects for the patient, such as damage to the surrounding tissue and / or pain and discomfort, or more serious complications. For example, in some cases, the bone may abut against soft tissue that may be damaged if the screw is too long, resulting in inflammation of or damage to the soft part. Additionally, screws protruding through the bone may be tactilely felt by the patient and may prevent soft tissue (e.g., tendons, ligaments, or muscles) from moving over the bone surface as intended, or even puncture the skin, which may lead to serious infections and complications.

[0005] Selection of the proper length screw is particularly important in spinal fixation procedures such as lumbar-sacral fusion and in the correction of spinal deformities such as scoliotic curvatures. As an example, screws installed in the pedicle portion of the human spine should not extend to the point where the screw contacts the spinal cord itself, an event that could cause irreparable neurological damage, including paralysis. Thus, determining the length of the hole is important in order to select the proper length screw.

[0006] During drilling, the surgeon is typically able to feel resistance on the drill to determine when it has penetrated through the bone. Because the simple act of drilling does not provide an accurate measurement of the depth in the bone itself, a depth gauge is typically employed to directly measure the depth of the hole from the top of the hole, to the side of the drill, to the bottom on the opposite side of the hole.

[0007] Currently, many designs are known and utilized for measuring the depth of a hole or bore in a portion of bone. Generally speaking, these designs utilize a central probe member having a barb at a distal end and a sleeve or channel member. The probe member is inserted into the pre-hole while the surgeon attempts to find the surface with the barb. More specifically, the probe member is inserted to a depth greater than the depth of the pre-hole such that the barb extends beyond the other side, at which point the surgeon finds the surface by latching the barb to the other side.

[0008] The probe member is received within the sleeve, i.e., the channel member, and may reciprocate relative thereto. The channel member has markings along a portion of its length, typically graduated in inches and / or millimeters. The markers are laterally affixed to the probe member such that as the probe member is biased relative to the channel member, the markers indicate the relative displacement between the probe member and the channel member. Thus, once the probe member is affixed to the opposite side of the bone, the channel member is biased relative to the probe member and toward the bone until the channel member abuts the bone surface. The depth gauge is then read by inspecting the graduated markings indicated by the probe member marker.

[0009] Several problems have been observed with the present depth gauges. First, the components are typically made from surgical grade stainless steel with graduated markings embossed into them. Thus, the brightness of operating room light on highly reflective surfaces can make the markings difficult to read. The markings are typically in small increments, such as a few millimeters, and surgeons often have difficulty discerning the markings or noting partial increments. Reading these gauges then often requires carefully holding the depth gauge as the reading is obtained, and the surgeon's efforts to closely inspect the reading can result in loss of the barb's engagement or hook on the bone, thus necessitating remeasurement and lost time.

[0010] Furthermore, proper reading of the markings requires that the surgeon's eyes are properly aligned with the markings. That is, proper viewing of the measurements requires the surgeon to view the gauge from a lateral perspective so that the view of the probe markers aligned with the graduated markings is proper and not distorted by the surgeon's elevated standing viewpoint. Thus, it is often necessary for the surgeon to bend down while using these gauges in order to view an accurate reading. If the depth gauge is tilted to take a reading, as explained above, the sleeve will shift relative to the probe, thus making the measurement inaccurate and possibly causing the barb to become unsecured. In addition, removal of the depth gauge often results in a loss of the measurement. Because the bone is essentially pinched between the distal end of the channel member and the distal barb of the probe member by light pressure, it is often necessary to retract the channel member from the bone surface to withdraw the probe from the pre-hole. Summary of the Invention [Means for solving the problem]

[0011] The present disclosure is a medical device for use in bone implant fixation procedures. The device is configured to provide faster and more accurate measurements of depth. In particular, the device includes a combination of a bone probe that allows for physical inspection of a hole drilled in bone, and a depth gauge member for determining the depth of the hole and providing a digital measurement of the depth. Thus, the device of the present disclosure is capable of digitally measuring the depth of an opening in a bone during the same surgical step in which the surgeon explores and inspects the interior of the opening.

[0012] In one aspect, the disclosure relates to a device for inspection and measurement of holes formed in bone. According to some embodiments, the device includes a handle with a bone probe extending from a distal end. The bone probe has a shaft with a distal end defining a probing tip including a portion with an engagement surface shaped to establish a hook with an exterior surface of the bone adjacent the hole. The device includes a depth gauge cylinder slidably mounted to a portion of the handle. The depth gauge cylinder comprises a hollow body with a lumen within which the handle and a portion of the bone probe shaft are received such that the depth gauge cylinder is operable to slide along a longitudinal axis of the handle. The device further includes a tip member mountable to a distal end of the depth gauge cylinder and operable to slide correspondingly with the depth gauge cylinder. The tip member includes an opening through which the bone probe shaft is received.

[0013] According to one aspect, the device further includes a sensor with a pressure sensitive strip coupled to a portion of the handle configured to generate an electronic signal that is received by the hollow body of the depth gauge cylinder and that varies in relation to the distance advanced by the depth gauge cylinder relative to the handle, the electronic signal being indicative of the depth of the hole.

[0014] In some cases, the device provides a measurement of the depth of a hole drilled into the bone, the measurement being determined by the distance traveled by the depth gauge cylinder relative to the handle of the device. More specifically, the measurement is based at least in part on a comparison between a location of a first contact made by a member protruding from an inner surface of the depth gauge cylinder onto the pressure sensitive strip and a location of a second contact between the member and the pressure sensitive strip, the distance between the two contact locations being indicative of the depth of the retainer in the bone.

[0015] During bone-related procedures involving the installation of screws or other fasteners, it may be desirable to determine whether the drilling of the hole has resulted in any cracks or openings, either along the inner sidewall of the hole or at the base of the hole. It is important to ensure the integrity of the drilled hole, since unintentional cracks, openings, or irregularities may increase the risk that the screw will not securely attach itself within the hole or may result in bone chipping or fragmentation during the tightening of the screw within the hole. Generally, due to the limited field of view within the hole (the drilled hole may be relatively small in width, such as 5 mm or less in some cases), it is not possible for the surgeon to visually inspect the integrity of the drilled hole.

[0016] The device of the present disclosure includes a bone probe that allows the surgeon to palpate the interior sidewall of the hole, locate any cracks or other unintentional openings or irregularities along the interior of the hole, and further determine the exit point of the hole (i.e., for a hole that has been drilled completely through the bone for subsequent placement of a bicortical screw or other fastener). The bone probe generally includes an elongated shaft that is slidably mounted within the body of the device and serves as a handle adapted for manual manipulation. The elongated shaft of the probe includes a distal end that is configured to extend from the body of the device during use. The distal end includes a probing tip for contacting the interior of the hole. At least a portion of the elongated shaft may be substantially flexible or semi-rigid to provide the surgeon with an appropriate "feel" during inspection of the hole in the bone. For example, the shaft of the bone probe may be substantially inelastic so that the surgeon can apply pressure against the inner wall of the hole and palpate as to the irregularity or base of the hole via tactile feedback provided by the shaft. In some embodiments, the shaft may be tapered such that the width or thickness of the shaft narrows in the direction toward the probing distal tip. In this manner, the flexibility of the shaft may increase along the shaft in the direction toward the probing tip.

[0017] The probing tip may include at least a first portion having a shape or contour that aids the surgeon in detecting surface irregularities (e.g., cracks, gaps, openings, etc.) on the interior surface of the hole. For example, in some embodiments, the first portion may have a generally arcuate or curved shape. The arcuate or curved portion may also aid the surgeon in locating the exit point of the hole (i.e., the second opening) to allow the probing tip to be precisely placed and secured along the edge of the exit point so that the hole can be measured via the depth gauge member. The arcuate or curved shape of the first portion of the probing tip may generally reduce the risk of tissue irritation that may otherwise occur along the interior surface of the hole, which is typically soft and easily penetrable with a less curved, more abrupt surface (with steep or distinct edges). In some embodiments, the first portion may have a generally spherical shape. In other embodiments, the first portion may be generally planar with rounded edges.

[0018] The probing tip also includes a second portion positioned opposite the first portion, the second portion including an engagement surface configured to pierce or otherwise establish a hook with the exterior of the bone immediately adjacent the exit point of the hole (i.e., along the edge of the hole). In particular, upon locating the exit point of the hole, i.e., the second opening, the surgeon may then extend the probing tip through the exit point, then position the bone probe shaft against the interior surface of the hole, and retract the bone probe shaft to withdraw the probing tip, specifically the engagement surface, back toward and into engagement with the exterior surface of the bone along the edge of the exit point of the hole. Upon sufficient application of pressure (i.e., sufficient retraction of the bone probe shaft), the engagement surface of the probing tip engages and establishes a hook with the bone immediately adjacent the hole. Upon establishment of the engagement, the medical device may be stabilized in a position at which the depth gauge member may now be used to measure the depth of the hole. In some embodiments, the engagement surface may include surface texturing to enhance friction between the engagement surface and a portion of the bone. For example, in some procedures where a plate or implant is to be secured with a screw through a bicortical drill hole, the probe tip may extend completely through the hole (from one side of the bone to the other), at which point the surgeon may pull the bone probe back toward the hole so that the engagement surface of the second portion of the probe tip establishes a hook with one side of the bone, with the surface texturing improving friction between the engagement surface and the bone and reducing the risk of slippage.

[0019] The bone probe is generally secured to a handle of the device, which may include a proximal end including a gripping portion, for example, to provide the surgeon with a means for applying a withdrawal force to withdraw an engagement surface of the probing tip of the bone probe into engagement with an exterior surface of the bone immediately adjacent a bicortical foramen in the bone.

[0020] The depth gauge member is generally a cylinder including a hollow extension slidably mounted to a portion of the handle. The depth gauge cylinder includes a lumen in which the handle and at least a portion of the bone probe shaft are received therein. The depth gauge cylinder is operable to slide along a longitudinal axis of the handle from an initial default position relative to the handle and an extended position. The tip member is releasably coupled to a distal end of the depth gauge cylinder and operable to slide correspondingly with the depth gauge cylinder during movement of the cylinder. The tip member includes an opening through which at least the bone probe shaft is received. The tip member further includes a distal end including a profile corresponding to the opening in the bone plate through which a screw is to be received.

[0021] More specifically, the tip member of the present disclosure is particularly useful in procedures where depth measurements are to be taken with the bone plate in place (i.e., positioned where it will be mounted). As is generally understood, it is preferable to countersink the screw when performing a bone implant fixation procedure to avoid any potential complications as a result of the screw head extending from the bone surface or bone plate. In bone plate holes (for receiving screws), there are known common countersink geometries, including at least tiny, small, and large fragments, with tiny fragments being the most common.

[0022] The profile of the distal end of the tip member comprises a stepped profile including a plurality of distinctly different discrete stepped portions, each having a different diameter. Each discrete stepped portion has a distinct shape and / or diameter corresponding to the shape and / or diameter of a common countersink size provided in the bone plate. The device further includes at least one sensor configured to generate an electronic signal indicative of the depth of the hole as a result of sensing the distance advanced by the depth gauge cylinder relative to the handle and bone probe.

[0023] For example, in one embodiment, upon establishing a hook with the exterior surface of the bone and generally providing an edge of the exit point of the drilled portion (or otherwise drilled hole) via the probing tip, the surgeon need only continue to pull back the handle, thereby maintaining engagement of the bone probe with the exterior surface of the bone, and then slide the depth gauge cylinder in a direction toward the bone. In response to sliding the depth gauge member toward the bone, at least a portion of the tip member will pass through an opening in the bone plate corresponding to the drilled hole until a portion of the stepped profile of the tip member contacts and engages with a countersink portion of the opening in the bone plate. When the tip member is correctly positioned within the countersink of the bone plate, the distal-most edge of the tip member will be aligned along the same plane as the bone-facing surface of the bone plate. The sensor is configured to generate an electronic signal based on the distance the depth gauge cylinder has advanced relative to the handle and bone probe, the electronic signal being indicative of at least the depth of the hole. In particular, the sensor may include an inductive or capacitive element or assembly configured to sense the location of the distal end of the depth gauge cylinder relative to a particular point along the handle, for example, and to generate an electronic signal representative of the distance therebetween as a result of the movement (i.e., sliding) of the depth gauge cylinder. For example, the depth gauge cylinder may generally slide between a proximal-most position, a distal-most position, and a number of positions therebetween, relative to the handle and bone probe. Thus, the depth gauge cylinder may be in the proximal-most position when in a default initial position when depth measurement has not yet been initiated. In response to establishing engagement between the bone probe tip and the bone, the depth gauge cylinder may then be advanced from the default initial position in a direction toward the bone until the tip member, specifically the stepped profile, contacts the countersink in the bone plate opening. The sensed distance traveled by the depth gauge cylinder is then used to calculate the depth of the hole. In particular, the device may include logic for determining the hole depth based on known variables.For example, the length of the bone probe shaft extending from the distal end of the tip member when the depth gauge cylinder is in an initial default position (i.e., the most proximal position relative to the handle) may be known and programmed into the logic. Thus, the sensed distance traveled by the depth gauge cylinder from the initial default position until the tip member, specifically the stepped profile, contacts the countersink in the bone plate opening may simply be subtracted from the known length of the bone probe shaft, thereby providing the hole depth.

[0024] Digital sensing of hole depth therefore provides a much more accurate measurement than traditional analog depth gauges and also requires little, if any, input or interpretation from the surgeon. Thus, by providing a much more accurate measurement of hole depth, the surgeon is able to select the correct length screw for any given hole to improve the chances of surgical success.

[0025] In some embodiments, the device may further include a display provided on either the handle or the depth gauge cylinder and configured to visually provide a digital readout of the hole depth measurement based on the electronic signal from the sensor. In other embodiments, the device may be configured to wirelessly communicate and exchange data with a separate display or computing device, such as, for example, a monitor or panel display, a PC, notebook, tablet computer, smartphone, or other wireless computing device.

[0026] In response to receiving the electronic signal from the sensor, a separate display or computing device may be configured to visually provide a hole depth measurement based on the electronic signal from the sensor. Additionally, in some embodiments, the computing device may include a specific software application that may be instructed to maintain a record of the hole measurements and / or provide an interactive user interface in which multiple holes may be mapped to a particular plate or implant and the depth of each hole (including the thickness of the plate or implant) may be included and stored for recordation. The present specification also provides, for example, the following items: (Item 1) 1. A device for the inspection and measurement of holes formed through bone, comprising: With handle, a bone probe secured to the handle and extending from a distal end thereof, the bone probe comprising a shaft, the shaft including a distal end defining a probing tip including at least a portion including an engagement surface shaped and configured to establish a hook with an exterior surface of a bone adjacent a hole in response to a sufficient application of force to the shaft; a depth gauge cylinder slidably mounted to a portion of the handle, the depth gauge cylinder comprising a hollow body including a lumen, the handle and at least a portion of the bone probe shaft being received within the lumen, the depth gauge cylinder being operable to slide along a longitudinal axis of the handle; a tip member releasably coupled to a distal end of the depth gauge cylinder and operable to slide relative to the depth gauge cylinder, the tip member comprising an opening, at least the bone probe shaft being received through the opening, the tip member further comprising a distal end; a sensor comprising a pressure sensitive strip, the sensor being coupled to a portion of the handle received by the hollow body of the depth gauge cylinder and configured to generate an electronic signal indicative of the depth of the hole; A device comprising: (Item 2) 2. The device of claim 1, wherein the electronic signal varies in relation to the distance traveled by the depth gauge cylinder relative to the pressure sensitive strip. (Item 3) 3. The device of claim 2, wherein the depth gauge cylinder is slidable along the length of the handle between a proximal-most position, a distal-most position and a number of positions therebetween. (Item 4) Item 4. The device of item 3, wherein the depth gauge cylinder comprises a member configured to contact a location on the pressure sensitive strip that indicates a position of the depth gauge cylinder along the length of the handle. (Item 5) 5. The device of claim 4, wherein the distance traveled by the depth gauge cylinder relative to the handle is detected by a sensed change in contact location between the member and the pressure sensor. (Item 6) 5. The device of claim 4, wherein the electronic signal is based on a measurement of distance between at least a first contact location and a second contact location between the member and the pressure sensitive strip. (Item 7) 5. The device of claim 4, wherein the member comprises at least one of a tab, a wiper arm, a spring, and a ball plunger. (Item 8) 5. The device of claim 4, wherein the pressure-sensitive strip has a width of approximately 5 mm to 12 mm. (Item 9) 5. The device of claim 4, wherein the pressure-sensitive strip has a length of approximately 70 mm. (Item 10) Item 5. The device of item 4, wherein the pressure sensitive strip is operatively associated with a processor. (Item 11) 5. The device of claim 4, further comprising an interlocking assembly comprising at least a first interlocking member associated with the depth gauge cylinder and a second interlocking member associated with the handle, the first and second interlocking members correspondingly engaging with each other when the depth gauge cylinder is in the distal-most position, thereby preventing the depth gauge cylinder from disengaging from the handle. (Item 12) Item 5. The device of item 4, wherein the portion of the handle received by the depth gauge cylinder comprises a cylindrical body. (Item 13) Item 1, the handle comprising at least a first body member coupled to a second body member to cooperatively form the handle. (Item 14) Item 14. The device of item 13, wherein the first and second body members encapsulate at least a portion of the sensor therein. (Item 15) Item 1 , wherein the handle comprises a rigid material. (Item 16) 2. The device of claim 1, wherein the sensor is partially enclosed within the handle to prevent contact by the operator's hand during use. (Item 17) 2. The device of claim 1, wherein a distal end of the depth gauge cylinder is operable to receive and releasably retain one of a plurality of tip members interchangeable therewith. (Item 18) 2. The device of claim 1, wherein the tip member comprises a universal distal tip. (Item 19) Item 19. The device of item 18, wherein the universal distal end profile comprises a stepped profile including at least two or more distinctly different and separate stepped portions, each stepped portion including a different diameter. (Item 20) 20. The device of claim 19, wherein the diameter of the at least two or more stepped portions decreases from a proximal-most stepped portion to a distal-most stepped portion. (Item 21) 21. The device of claim 20, wherein the universal tip comprises an inclined surface between the stepped portions. (Item 22) 21. The device of item 20, wherein the universal tip is configured to fit multiple bone plates. [Brief description of the drawings]

[0027] Features and advantages of the claimed subject matter will become apparent from the following detailed description of consistent embodiments thereof, which should be considered in conjunction with the accompanying drawings.

[0028] [Figure 1] FIG. 1 is a top view of one embodiment of a medical device consistent with this disclosure. [Diagram 2] 2 is a cross-sectional view of the medical device of FIG. 1 illustrating the hollow interior of the handle and the arrangement of the bone probe and depth gauge members relative to one another. [Figure 3A] 3A and 3B are enlarged front and side views, respectively, of one embodiment of a probing tip defined on the distal end of a bone probe shaft. [Figure 3B] 3A and 3B are enlarged front and side views, respectively, of one embodiment of a probing tip defined on the distal end of a bone probe shaft. [Figure 3C] 3C and 3D are enlarged front and side views, respectively, of another embodiment of a probing tip defined on the distal end of a bone probe shaft. [Figure 3D] 3C and 3D are enlarged front and side views, respectively, of another embodiment of a probing tip defined on the distal end of a bone probe shaft. [Figure 4] 4 is a perspective view of another embodiment of a bone probe compatible for use with the medical device of FIG. 1 illustrating another embodiment of a probing tip defined on a distal end of the bone probe shaft. [Diagram 5] 5 and 6 are front and side views, respectively, of the bone probe of FIG. [Figure 6] 5 and 6 are front and side views, respectively, of the bone probe of FIG. [Figure 7] FIG. 7 is an enlarged side view of the probe tip of FIG. [Figure 8] 8 and 9 are enlarged perspective views of the probe tip of FIG. [Figure 9] 8 and 9 are enlarged perspective views of the probe tip of FIG. [Figure 10] 10A and 10B illustrate retraction of the bone probe within the handle member and subsequent compression of the spring assembly in response to movement of the handle toward the bone when the probing tip at the distal end of the bone probe shaft is in contact with the bottom of a drilled hole in the bone. [Figure 11] FIG. 11 is a side view of the medical device of FIG. 1 including a strain sensor that senses strain on the bone probe shaft and provides an electronic signal indicative of the strain to an audio or visual component for providing an audible or visual alert. [Figure 12] 12A-12F illustrate a sequence of steps for performing a procedure to probe a drilled hole and subsequently obtain depth measurements using another embodiment of a medical device consistent with the present disclosure. [Figure 13] 13A-13C illustrate a series of steps for performing a procedure using the bone probe of FIG. 4 to probe a fully drilled hole (i.e., a hole that extends completely through the bone for receipt of a bi-cortical bone screw) and further establishing a hook between the probing tip of the bone probe and the side of the bone adjacent the bi-cortical drill hole, securing the bone probe in place and allowing a depth gauge member to be used to measure the depth of the bi-cortical drill hole. [Figure 14] FIG. 14 is another embodiment of a medical device consistent with the present disclosure having a display for providing a digital readout of the hole depth measurement. [Figure 15]FIG. 15 is another embodiment of a medical device consistent with the present disclosure configured to wirelessly communicate and transmit depth measurement data to a wireless computing device for recording, storing, and / or visually displaying the measured depth. [Figure 16] 16 and 17 illustrate the compatibility of the medical device of the present disclosure with other medical devices to provide additional features such as energy emission (FIG. 16) and sensing capabilities (FIG. 17) for additional bone exploration and depth measurement. [Figure 17] 16 and 17 illustrate the compatibility of the medical device of the present disclosure with other medical devices to provide additional features such as energy emission (FIG. 16) and sensing capabilities (FIG. 17) for additional bone exploration and depth measurement. [Figure 18] FIG. 18 is a perspective view of a medical device having a neuromonitoring port configured to receive a corresponding input connector from a neurosensing / neurostimulation device and provide an electrical pathway to a bone probe consistent with the present disclosure. [Figure 19] 19 is a side view of the medical device of FIG. 18 illustrating, in partial cross-section, the configuration of a bone probe shaft for carrying electrical signals to and from a neurosensing / neurostimulation device. [Figure 20] 20A, 20B, and 20C illustrate the transmission of signals from a bone probe to a screw positioned within a hole in the spine for neuromonitoring capabilities. [Figure 21] FIG. 21 illustrates an angle guide for use with a medical device of the present disclosure. [Figure 22] FIG. 22 is a perspective view of another embodiment of a medical device consistent with the present disclosure. [Diagram 23] 23 is a perspective exploded view of the medical device of FIG. 22. FIG. [Figure 24] 24 is a top view of the medical device of FIG. 22 illustrating the depth gauge cylinder in an initial default position relative to the handle and bone probe. [Diagram 25]25 is a cross-sectional view of the medical device taken along line 25-25 of FIG. [Figure 26] 26 is a side view of the medical device of FIG. 22. FIG. [Figure 27] 27 is a perspective view of the medical device of FIG. 22 illustrating movement of the depth gauge cylinder relative to the handle and bone probe. [Figure 28] FIG. 28 is a perspective view of another embodiment of the medical device of FIG. 22 illustrating a user-operated control mechanism provided on the handle. [Figure 29] 29A, 29B, and 29C are enlarged side views of the tip member illustrating stepped profiles of various dimensions. [Diagram 30] FIG. 30 is a side view of another embodiment of the medical device of FIG. 22 including a unitary body construct. [Diagram 31] FIG. 31 is an enlarged side view of the tip member. [Diagram 32] 32 and 33 are perspective views illustrating a customized grip on a portion of another medical device consistent with the present disclosure. [Diagram 33] 32 and 33 are perspective views illustrating a customized grip on a portion of another medical device consistent with the present disclosure. [Diagram 34] FIG. 34 is a perspective exploded view of another embodiment of a medical device consistent with the present disclosure. [Diagram 35] 35 is a perspective view of the medical device of FIG. 34 in an assembled state illustrating movement of the depth gauge cylinder relative to the handle and bone probe. [Diagram 36] FIG. 36 is a top view of the medical device of FIG. 34 illustrating the depth gauge cylinder in a distal-most position relative to the handle and bone probe. [Figure 37] FIG. 37 is a cross-sectional view of the medical device taken along line 37-37 of FIG. [Figure 38] 38 is a side view of the medical device of FIG. [Figure 39] FIG. 39 is a perspective view of another embodiment of a medical device consistent with the present disclosure. [Diagram 40] 40 is a perspective exploded view of the medical device of FIG. [Diagram 41] FIG. 41 is a top view of the medical device of FIG. 39 illustrating the depth gauge cylinder in an initial default position relative to the handle and bone probe. [Diagram 42] FIG. 42 is a cross-sectional view of the medical device taken along line 42-42 of FIG. [Diagram 43] 43 is a side view of the medical device of FIG. [Figure 44-1] 44A-44E illustrate a series of steps for performing a procedure using an embodiment of a medical device consistent with the present disclosure to probe a fully drilled hole (i.e., a hole extending completely through the bone for receipt of a bi-cortical bone screw) with a bone probe (similar to the bone probe of FIG. 4), establish a hook between the probing tip of the bone probe and the side of the bone adjacent the bi-cortical drill hole, secure the bone probe in place, and subsequently obtain a depth measurement. [Figure 44-2] 44A-44E illustrate a series of steps for performing a procedure using an embodiment of a medical device consistent with the present disclosure to probe a fully drilled hole (i.e., a hole extending completely through the bone for receipt of a bi-cortical bone screw) with a bone probe (similar to the bone probe of FIG. 4), establish a hook between the probing tip of the bone probe and the side of the bone adjacent the bi-cortical drill hole, secure the bone probe in place, and subsequently obtain a depth measurement. [Diagram 45] 45 and 46 are perspective views of another embodiment of a medical device consistent with the present disclosure. [Figure 46] 45 and 46 are perspective views of another embodiment of a medical device consistent with the present disclosure. [Figure 47] FIG. 47 is an exploded view of the medical device shown in FIGS. [Figure 48]FIG. 48 is a bottom view of the sensor depicted in FIG. 47 illustrating the pressure sensitive strip. [Figure 49] FIG. 49 is a perspective view of a bottom handle portion of a medical device. [Figure 50] 50 and 51 are cross-sectional views of a medical device illustrating the depth gauge cylinder in different positions relative to the handle. [Figure 51] 50 and 51 are cross-sectional views of a medical device illustrating the depth gauge cylinder in different positions relative to the handle. [Figure 52] FIG. 52 is an enlarged cross-sectional view of the depth gauge cylinder and handle illustrating one embodiment of a member associated with the depth gauge cylinder that engages a pressure sensitive strip consistent with this disclosure. [Figure 53] FIG. 53 is an enlarged cross-sectional view of a portion of a depth gauge cylinder and handle coupled together illustrating another embodiment of a member associated with the depth gauge cylinder that engages a pressure sensing strip consistent with the present disclosure. [Figure 54] 54 and 55 are enlarged cross-sectional views of a portion of a depth gauge cylinder and handle coupled together illustrating an interlocking assembly for retaining the depth gauge cylinder and handle together, the interlocking assembly transitioning between at least a first configuration (FIG. 54) and a second configuration (FIG. 55). [Figure 55] 54 and 55 are enlarged cross-sectional views of a portion of a depth gauge cylinder and handle coupled together illustrating an interlocking assembly for retaining the depth gauge cylinder and handle together, the interlocking assembly transitioning between at least a first configuration (FIG. 54) and a second configuration (FIG. 55). [Figure 56] FIG. 56 is an exploded view of a medical device illustrating another embodiment of a member associated with a depth gauge cylinder that engages a pressure sensing strip consistent with the present disclosure. [Figure 57] FIG. 57 is an enlarged cross-sectional view of a portion of the depth gauge cylinder and handle of the device of FIG. 56 illustrating the members that are engaged with the pressure sensitive strip. [Figure 58] FIG. 58 is a side perspective view of a tip member consistent with this disclosure. [Figure 59] 59 is a cross-sectional view of the tip member taken along line AA of FIG. 58.

[0029] For a complete understanding of the present disclosure, please refer to the following detailed description, including the appended claims, in conjunction with the drawings described above. Although the present disclosure is described in connection with exemplary embodiments, it is not intended that the disclosure be limited to the specific forms described herein. It will be understood that various omissions and substitution of equivalents are contemplated as the circumstances may suggest or deem expedient. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0030] In overview, the present disclosure is generally directed to a medical device configured to provide faster and more accurate measurements of depth for use in bone implant fixation procedures. In particular, the device includes a combination of a bone probe that allows for physical inspection of a hole drilled in bone, and a depth gauge member for determining the depth of the hole and providing a digital measurement of the depth. Thus, the device of the present disclosure is capable of digitally measuring the depth of an opening in a bone during the same surgical step in which the surgeon explores and inspects the interior of the opening.

[0031] FIG 1 is a top view of one embodiment of a medical device 100 consistent with the present disclosure, and FIG 2 provides a cross-sectional view of the medical device 100. As shown, the medical device 100 includes a body 102 having a first end 104 and an opposing second end 106 and is generally hollow. The body 102 is configured as a handle and is generally adapted for manual manipulation. Thus, the body will be referred to hereinafter as "handle 102" for ease of description.

[0032] The device 100 further includes a bone probe 108 slidably mounted within the handle 102. The bone probe 108 includes a shaft 110 having a distal end 112 configured to extend from and retract toward the first end 104 of the handle 102 during use, as will be described in more detail herein. The distal end 112 further includes a probing tip 114, which is useful for examination and inspection of the interior surface of a hole drilled in a bone, as will be described in Figures 3A and 3B.

[0033] The device 100 further includes a depth gauge member 116 slidably mounted within the handle 102. The depth gauge member 116 generally includes a hollow extension 118 having a distal end 120 configured to extend from and retract toward the first end of the handle 102 during use, similar to the bone probe shaft 110, as will be described herein. The hollow extension 118 has a lumen in which at least a portion of the bone probe shaft 110 is received such that the bone probe 108 and the depth gauge member 116 are independently slidable relative to one another and the handle 102. The device 100 further includes one or more depth measurement sensors 122 configured to generate an electronic signal indicative of at least a depth of the bore, the electronic signal varying in relation to a distance between the first end 104 of the handle 102 and the distal end 120 of the depth gauge member 116, as will be described in more detail herein.

[0034] The bone probe 108 and the depth gauge member 116 may each be coupled to a separate slider member to allow the surgeon to manually control the movement of the bone probe 108 and the depth gauge member 116 independent of one another. For example, as shown in FIG. 1, a first slider 124 may be coupled to at least the bone probe shaft 110 and is slidable along the longitudinal axis of the handle 102, such movement of the first slider 124 causing corresponding movement of the bone probe shaft 110. Although not shown in FIGS. 1 and 2, a second slider may be coupled to the depth gauge member 116 and is similarly slidable along the longitudinal axis of the handle 102, such that movement of the second slider causes corresponding movement of the depth gauge member 116.

[0035] The device 100 may further include a spring assembly 126 coupled to at least one of the bone probe 108 and the depth gauge member 116. The spring assembly 126 may be configured to provide a biasing force on at least one of the bone probe 108 and the depth gauge member 116 to maintain either the bone probe 108 or the depth gauge member 116 in a default extended position. For example, as shown in Figures 1 and 2, the bone probe 108 is generally positioned in an extended configuration (with the probing tip 114 extended out of the first end 104 of the handle 102) where the surgeon may inspect the interior surface of the drilled hole as shown in Figures 10A and 10B.

[0036] During bone-related procedures involving the installation of screws or other fasteners, it may be desirable to determine whether the drilling of the hole has resulted in any cracks or openings, either along the inner sidewall of the hole or at the base of the hole. It is important to ensure the integrity of the drilled hole, since unintentional cracks, openings, or irregularities may increase the risk that the screw will not securely attach itself within the hole or may result in bone chipping or fragmentation during the tightening of the screw within the hole. Generally, due to the limited field of view within the hole (the drilled hole may be relatively small in width, such as 5 mm or less in some cases), it is not possible for the surgeon to visually inspect the integrity of the drilled hole.

[0037] The bone probe 108 allows the surgeon to palpate the interior sidewalls and bottom of the drilled hole to locate any cracks or other unintentional openings or irregularities along the interior of the hole. For example, the probing tip 114 is configured for contacting the interior of the hole, and at least a portion of the elongated shaft 110 may be substantially flexible or semi-rigid to provide the surgeon with a suitable "feel" during inspection of the hole in the bone. For example, the shaft 110 of the bone probe 108 may be substantially inelastic so that the surgeon may apply pressure against the inner wall of the hole and palpate as to any irregularities or base of the hole via tactile feedback provided by the shaft 110. In some embodiments, the shaft 110 may be tapered such that the shaft narrows in width or thickness in the direction toward the probing distal tip. In this manner, the flexibility of the shaft may increase along the shaft in the direction toward the probing tip 114.

[0038] 3A and 3B are enlarged front and side views, respectively, of one embodiment of a probing tip 114a defined on the distal end 112 of the bone probe shaft 110. As shown, the probing tip 114a may include an arcuate first portion 128 that is shaped and configured to contact the interior surface of the bore with little or no resistance and provide tactile feedback of the interior surface to the surgeon. For example, as shown, the first portion 128 is generally curved or spherical to prevent or minimize the risk that the probing tip 114a would penetrate or otherwise engage a portion of the interior surface of the bore. Rather, the first portion 128 is shaped to glide or easily slide along the interior surface while still allowing sufficient contact to provide tactile feedback to the surgeon. Thus, the arcuate first portion 128 may reduce or eliminate tissue irritation that may otherwise occur when a sharper object is used to probe the bone opening.

[0039] The probing tip 114a further includes a second portion 130 having an engagement surface shaped and configured to establish a hook with a portion of the interior surface of the hole in response to sufficient application of force to the shaft and associated with the bottom of the hole. The engagement surface may be a generally abrupt edge (e.g., a sharp corner or edge) of the probing tip 114 where the transition between the first portion 128 and the second portion 130 is abrupt. Thus, in response to sufficient pressure, the engagement surface is configured to pierce or establish a hook with tissue in the interior of the hole. Thus, the probing tip 114a is multifunctional in that the first portion 128 provides a "feel" to the surgeon for inspection purposes and also allows probing of the interior surface to locate the bottom of the hole, and the second portion 130 allows the surgeon to establish a hook at a desired site (i.e., the bottom of the hole) to stabilize the bone probe in a desired location at which point the depth gauge member may be used to measure the depth of the hole.

[0040] In some embodiments, the engagement surface of the second portion 130 may include surface texturing to improve friction between the engagement surface and a portion of the bone. For example, in some procedures where a plate or implant is to be secured with a screw through a bicortical drill hole, the probe tip may extend completely through the hole (from one side of the bone to the other), at which point the surgeon may pull the bone probe back toward the hole such that the engagement surface of the second portion of the probe tip establishes a hook with one side of the bone, with the surface texturing improving friction between the engagement surface and the bone and reducing the risk of slippage.

[0041] 3C and 3D are enlarged front and side views, respectively, of another embodiment of a probing tip 114b defined on the distal end 112 of the bone probe shaft 110. As shown, the probing tip 114b may include a first portion 129 that is shaped and configured to contact the interior surface of the bore with little or no resistance and provide tactile feedback of the interior surface to the surgeon. For example, as shown, the first portion 129 has a generally planar or flat surface with rounded edges to prevent or minimize the risk that the probing tip 114b will penetrate or otherwise engage a portion of the interior surface of the bore. Rather, the rounded edges of the first portion 129 are shaped to glide or easily slide along the interior surface while still allowing sufficient contact to provide tactile feedback to the surgeon. A generally planar surface may, in some circumstances, provide a more accurate depth measurement than a full radius bottom in that the flat surface may provide better engagement with and seat more flush with the bottom of the hole than the full radius first portion 128 of the probe tip 114a (FIGS. 3A and 3B). Note, however, that a rounded edge may still provide a sufficient edge to serve as an engagement surface for establishing a hook with a portion of the interior surface of the hole and associated with the bottom of the hole upon sufficient application of force to the shaft. The second portion 131 of the probe tip 114b may be generally curved or spherical.

[0042] 4 is a perspective view of another embodiment of a bone probe 208 compatible for use with a medical device 100 consistent with the present disclosure. Similar to the bone probe 108 described previously herein, the bone probe 208 allows the surgeon to palpate the interior sidewall of the hole and locate any cracks or other unintentional openings or irregularities along the interior of the hole, and in combination with the depth gauge member 116, the bone probe 208 further allows for depth measurement of the hole. In particular, as described in more detail herein, the bone probe 208 is configured to aid in the measurement of drilled holes extending completely through bone (i.e., bicortical drill holes) where bicortical screws or other bicortical fasteners will be placed. Thus, unlike bone probe 108, which has a bone probing tip that is generally configured to locate the base or bottom of a drilled hole in a bone that does not extend completely through the bone, bone probe 208 specifically includes a bone probing tip that is configured to extend completely through a drilled hole (from one side of the bone to the other), at which point the surgeon may pull the bone probe back toward the hole so that the engagement surface of the bone probing tip establishes a hook with one side of the bone, thereby anchoring or securing bone probe 208 in place and enabling subsequent depth measurement of the hole via the depth gauge member in the manner described previously herein.

[0043] The bone probe 208 includes a shaft 210 having a proximal end 211 and an opposing distal end 212 configured to extend from and retract toward the first end 104 of the handle 102 during use, as will be described in more detail herein. The proximal end 211 may further include a cutout portion (i.e., notch) 213 that allows the bone probe shaft 210 to be physically coupled to a control mechanism or equivalent (e.g., slider 124) for extending / retracting the shaft 210. The distal end 212 includes a probing tip 214, which is useful for examining and inspecting the interior surface of a hole drilled in bone in a manner similar to the probing tip 114.

[0044] The bone probe 208 allows the surgeon to palpate the interior sidewalls of the drilled hole to locate any cracks or other unintentional openings or irregularities along the interior of the hole. For example, the probing tip 214 is configured for contacting the interior of the hole, and at least a portion of the elongated shaft 210 may be substantially flexible or semi-rigid to provide the surgeon with a suitable "feel" during inspection of the hole in the bone. For example, the shaft 210 of the bone probe 208 may be substantially inelastic so that the surgeon can apply pressure against the inner wall of the hole and palpate as to any irregularities or base of the hole via tactile feedback provided by the shaft 210.

[0045] In some embodiments, the shaft 210 may taper such that the shaft narrows in width or thickness in a direction toward the probing distal tip 214. In this manner, the flexibility of the shaft may increase along the shaft 210 in a direction toward the probing tip 214. For example, in the illustrated embodiment, the shaft 210 may have a generally cylindrical geometry along a majority of its length and may include a generally planar portion formed along its length that tapers in a direction toward the distal end 212. For purposes of ease of discussion and illustration, the following description will refer to the shaft 210 as having a first side 216 that includes a cylindrical shape and a second side 218 that is generally planar and extends along the length of the shaft 210, and the shaft tapers in thickness (i.e., transitions from a greater thickness to a lesser thickness along the length of the shaft 210) from the proximal end 211 to the distal end 212, as shown in FIGS.

[0046] In particular, FIG. 5 is a front view of the bone probe 208 (i.e., facing in a direction toward the second side 218 of the shaft) and FIG. 6 is a side view of the bone probe 208. As shown in FIG. 5, the overall width of the shaft 210 remains relatively constant from the proximal end 211 to the distal end 212, while as shown in FIG. 6, the thickness of the shaft 210 tapers from the proximal end 211 to the distal end 212. For example, the bone probe 208 may be formed from a single cylindrical piece of medical grade material (e.g., a rod of metal such as stainless steel, nitinol, or aluminum). The second side 218 may be formed using a subtractive manufacturing process, such as grinding, milling, or the like, thereby removing material from the shaft 210 to form a generally planar surface of the second side 218. Additionally, the tip 214 is further formed using grinding, milling, or other techniques to remove material from the shaft 210 to form a hook-like design, as will be described in more detail herein with reference to Figures 7, 8, and 9. Thus, as shown in Figure 5, the width W1 at the proximal end 211 is approximately equal to the width W2 at the distal end 212 and tip 214. As shown in Figure 6, the thickness T1 at the proximal end 211 exceeds the thickness T2 at the distal end 212, while the thickness T1 is approximately equal to the thickness T3 at tip 214. Thus, a taper in the thickness of the shaft 210 occurs along the substantially planar second side 218 as a result of the formation of the second side 218 (i.e., removing shaft material and machining to create a substantially planar surface).

[0047] FIG. 7 is an enlarged side view of the probing tip 214, and FIGS. 8 and 9 are enlarged perspective views of the probing tip 214. As shown, the tip 214 may generally resemble a barb or equivalent extending from the distal end 212 of the probe shaft 210 and oriented at an angle relative to the shaft 210, where such angle may be approximately perpendicular to the longitudinal axis of the shaft 210. However, it should be noted that the probing tip 214 may be oriented at an obtuse or acute angle relative to the longitudinal axis of the shaft 210. The probing tip 214 may include a base portion 220 that is shaped and configured to contact the interior surface of the bore with little or no resistance and provide tactile feedback of the interior surface to the surgeon. For example, as shown, the base portion 220 may have a generally curved or arcuate edge to prevent or minimize the risk that the probing tip 214 will penetrate or otherwise engage a portion of the interior surface of the bore. Rather, base portion 220 may be shaped to glide or slide easily along the interior surface while still allowing sufficient contact to provide tactile feedback to the surgeon. Thus, base portion 220 may reduce or eliminate tissue irritation that may otherwise occur when sharper objects are used to probe the bone opening.

[0048] The probing tip 214 further includes an upper portion 222 having a generally planar surface oriented at a first angle θ1 relative to the longitudinal axis A of the shaft 210 and at a second angle θ2 relative to a plane 221 along which the base portion 220 is generally parallel. In some embodiments, the surface of the upper portion 222 may be generally perpendicular to the axis A, and thus the angle θ1 may be approximately 90 degrees. However, in some embodiments, the surface of the upper portion 222 may be oriented at an offset angle relative to the axis A. For example, as shown in Figures 7-9, the angle θ1 may be an acute angle (i.e., less than 90 degrees). In some embodiments, the angle θ1 may be between 1 and 89 degrees. In some embodiments, the angle θ1 may be between 5 and 25 degrees. However, in some embodiments, the angle θ1 may be an obtuse angle (i.e., greater than 90 degrees). In some embodiments, the angle θ1 may be between 91 and 179 degrees. In some embodiments, the angle θ1 may be between 95 and 115 degrees. With reference to the second angle θ2, in some embodiments, the surface of the top portion 222 may be approximately parallel to the plane 221, and thus the angle θ2 is approximately 0 degrees. However, in some embodiments, the surface of the top portion 222 may be oriented at an offset angle relative to the plane 221. For example, as shown in FIGS. 7-9, the surface of the top portion 222 may be offset relative to the plane 221, and thus the angle θ2 may be approximately 1-89 degrees. In some embodiments, the angle θ2 may be approximately 5-25 degrees.

[0049] The probing tip 214 further includes a groove or notch 224 formed adjacent the distal end 212 of the probe shaft 210, as will be described in more detail herein, which results in less shaft material being present at the junction between the probing tip 214 and the distal end 212 of the shaft 210, which allows for increased deflection of the tip 214 relative to the shaft 210 for improved engagement of the tip 214 with a portion of bone. The probing tip 214 further includes an engagement surface 226, in the form of a lip, defined along the periphery of the upper portion 222. The engagement surface 226 is shaped and configured to establish an engagement with a portion of bone, specifically, with the side of the bone immediately adjacent the opening of the drilled hole through which the probing tip has passed. In particular, as will be described in more detail herein, in response to an operator extending the probing tip 214 completely through a bicortical drill hole (i.e., a drilled hole that extends completely from one side of the bone through the other side of the bone), the engagement surface 226 is shaped and configured to establish a hook with a portion of the opposing side of the bone directly adjacent the opening of the drilled hole, in response to an actuation from the surgeon. The engagement surface 226 may be a generally abrupt edge (e.g., a sharp corner or edge) of the probing tip 214 where the transition between the base portion 220 and the top portion 222 is abrupt. Thus, in response to sufficient pressure, the engagement surface 226 is configured to pierce or establish a hook with a portion of the opposing side of the bone for subsequent depth measurements, thereby anchoring the bone probe shaft 210 in place.

[0050] Thus, the probing tip 214 is multifunctional in that the base portion 220 provides the surgeon with a "feel" for inspection purposes and also allows probing of the interior surface to locate the opposing side of the bone, and the top portion 222 allows the surgeon to establish a hook at a desired site (i.e., a portion of the opposing side of the bone adjacent the opening of the drilled hole) to stabilize the bone probe in a desired location at which point the depth gauge member may be used to measure the overall depth of the hole. In some embodiments, the engagement surface 226 of the top portion 222 may include surface texturing to improve friction between the engagement surface 226 and the portion of the bone, reducing the risk of slippage during bicortical depth measurements.

[0051] Additionally, as explained above, the grooves 224 present at the junction between the distal end 212 of the probe shaft 210 and the probing tip 214 allow for increased deflection of the tip 214 relative to the shaft 210 to improve engagement of the tip 214 with a portion of the bone adjacent the opening of the hole. For example, upon advancing the probing tip 214 completely through the hole, the surgeon may then position the generally planar second side 218 against the interior surface of the drilled hole and then retract (i.e., pull back) the probe shaft 210 such that the upper portion 222 of the probing tip 214 contacts a portion of the opposing side of the bone directly adjacent the opening of the hole. As the surgeon pulls the bone probe shaft 210 back towards the hole, the groove 224 allows additional flexing of the probing tip 214 relative to the remainder of the probe shaft 210 due to less material at the junction between the shaft 210 and the tip 214 at the groove 224, which will improve hooking or gripping of the engagement surface 226 of the top portion 222 of the probing tip with the opposing side of the bone. Additionally, the tapered thickness of the shaft 210 provided by the generally planar second side 218 allows deflection or flexing of the shaft 210 on one axis such that when the probing tip 214 is generally perpendicular to the shaft 210, as generally shown, application of pressure on the shaft 210 will result in deflection of the probing tip 214, and in particular the engagement surface 226, into an upwardly angled state, thereby allowing for superior hooking or gripping of the exterior surface of the opposing side of the bone.

[0052] It should be noted that the bone probe 208 may also be used to obtain the depth of drilled holes that are not bicortical (i.e., do not extend completely through the bone from one side to the other). For example, the engagement surface 226 may establish a hook with a portion of the interior surface of the hole and associate with the bottom of the hole upon sufficient application of force to the shaft 210 and then the tip 214. The engagement surface 226 may be a generally abrupt edge (e.g., a sharp corner or edge) of the probe tip 114 where the transition between the base portion 220 and the top portion 222 is abrupt. Thus, upon sufficient pressure, the engagement surface 226 is configured to pierce or establish a hook with tissue within the hole. Thus, in response to application of force to the probing tip 214, such as when a surgeon presses the probing tip 214 against the interior of a bore, the groove 224 allows additional flexing of the probing tip 214 relative to the remainder of the probe shaft 210 due to less material at the junction between the shaft 210 and the tip 214 at the groove 224, which will improve hooking or gripping the surface of the bore via the engagement surface 226. Additionally, the tapered thickness of the shaft 210 provided by the generally planar second side 218 allows for deflection or flexing of the shaft 210 on one axis such that when the probing tip 214 is generally perpendicular to the shaft 210, as generally shown, application of pressure on the shaft 210 results in deflection of the probing tip 214, and in particular the engagement surface 226, into an upwardly angled state, thereby allowing for superior hooking or gripping of the interior surface of the bore.

[0053] 10A and 10B illustrate the initial process of inspecting a drilled hole 134 in a bone 132 via the bone probe 108. For example, as described previously herein, the biasing force from the spring assembly 126 may be sufficient to maintain the bone probe 108 in an extended position while the surgeon probes the interior surface 136 of the drilled hole 134 and locates the bottom 138 of the hole 134. However, as shown in FIG. 10B, once the desired target site is located, such as locating the bottom 138 of the hole 134, the biasing force may be overcome in response to the surgeon moving the handle 102 in a direction toward the hole 134. The surgeon can move the handle 102 until the first end 104 of the handle 102 abuts either the surface of the bone 132 or the surface of the plate or implant 140, as indicated by arrow 142, thereby maintaining the placement of the feeling tip 114 at the bottom 138 of the hole 134 while causing compression of the spring assembly 126, as indicated by arrow 144. At this point, the depth gauge member 116 can be advanced in a direction towards the hole 134 such that the hollow shaft 118 slides over the bone probe shaft 110, which generally acts as a guide and holds position as a result of the engagement surface of the second portion 130 of the feeling tip 114 having an established hook with the bottom 138 of the hole 134. The depth gauge member 116 can be extended through the hole 134 until the distal end 120 of the depth gauge member 116 abuts the bottom 138 of the hole 134. Thus, the one or more depth measuring sensors 122 can then generate an electronic signal related to the distance between the first end 104 of the handle 102 and the distal end 120 of the depth gauge member 116, the electronic signal being indicative of the depth of the hole 134 and the thickness of the plate or implant 140.

[0054] The device 100 of the present disclosure may include a variety of different sensing devices suitable for determining the length or depth of the drilled hole or bore to be measured. For example, the one or more depth measurement sensors 122 may include electromechanical or electronic sensors, such as, but not limited to, linear encoders, and may employ any one or more of acoustic, ultrasonic, capacitive, electric field, inductive, electromagnetic (e.g., Hall effect type), and optical components to determine relative or absolute distance measurements. In some embodiments, the sensor 122 may be configured to measure, sense, distinguish, or otherwise determine the length, i.e., distance, between at least the first end 104 of the handle 102 and the distal end 120 of the depth gauge member 116.

[0055] 10A and 10B, at least a first sensor element 122a is positioned proximate the first end 104 of the handle 102 and a second sensor element 122b is positioned on the depth gauge shaft 118 proximate the distal end 120. The sensor elements 122a, 122b are configured to measure at least one of relative, absolute, and incremental movement (e.g., distance, speed, etc.) of the depth gauge shaft 118 relative to the first end 104 of the handle 102 during a measurement procedure. For example, in one embodiment, the sensor elements 122a, 122b may be used to measure an absolute distance that the distal end 120 of the depth gauge 116 is moved relative to a fixed reference point, such as, for example, the first end 104 of the handle 102.

[0056] The first sensor element 122a may be an active inductive, capacitive, or optical element that communicates with circuitry (e.g., a controller) of a user interface portion of the device (e.g., a GUI display or equivalent with user input). The first sensor element 122a may include one or more longitudinally extending conductors, e.g., wires, cables, or traces on a printed circuit board, such as a flex circuit or equivalent. Additionally, the first sensor element 122a may further include multiple inductive, capacitive, or optical elements that may be coupled to and disposed on the longitudinally extending conductors. The second sensor element 122b may be configured on the depth gauge shaft 118 in a manner to cooperate with the first sensor element 122a proximate the first end 104 of the handle 102. For example, the second sensor element 122b may generally be a passive element, such as a permanent magnet, an optical element (e.g., a marker), or the like, configured to cooperate, communicate, or otherwise interact with the first sensor element 122a. For example, during a measurement procedure, movement of the depth gauge 116 out of the handle 102 of the device results in an interaction between the first and second sensor elements 122a, 122b. In particular, as the depth gauge 116 extends from the handle 102 of the device, the first and second sensor elements 122a, 122b move relative to one another (i.e., the second sensor element 122b moves past the first sensor element 122a) and, in combination with one another, provide a signal (e.g., a pulse, etc.) to circuitry that processes the signal, displays a distance measurement on a display, and / or transmits the signal to a separate computing device.

[0057] In various embodiments of the invention, one or more sensors 122 may be connected to a microprocessor and / or other digital electronic device to produce an output for an electronic display, such as a liquid crystal display or light emitting diode display, and / or for wireless / wired transmission of an electronic signal containing the measurement data to a wireless compatible computing device. For example, in some embodiments, the microprocessor or other digital electronic device may be connected to a wireless transmitter for wireless transmission of the electronic signal. In some embodiments, a signal conditioning circuit may intermediate the inductive or capacitive elements of the electronic sensor and the microprocessor or other digital electronic device used to drive the display, thus ensuring that the correct input current and voltage levels are provided to the various components. The device may further include a power source, such as a primary or secondary battery, which may be connected directly to the signal conditioning circuit or to the microprocessor.

[0058] It should be noted that the device 100 of the present disclosure may include a variety of different electronic sensors and circuitry assemblies for determining and transmitting depth measurements, including the sensors and systems discussed in U.S. Pat. Nos. 7,165,336, 7,444,756, 7,493,703, 7,607,238, 7,676,943, 7,685,735, 7,730,629, 7,895,762, and 7,895,767 (the contents of each of which are incorporated herein by reference in their entirety).

[0059] 11 is a side view of a medical device 100 including a strain sensor 146 for sensing strain on the bone probe shaft 110 as a result of probing the inner surface of the drilled hole. The sensor 146 may include a strain gauge or equivalent configured to determine the strain on the bone probe shaft 110, which may be useful to alert the surgeon to the amount of resistance the distal probing tip 114 is experiencing during probing of the interior of the hole. For example, the surgeon may be able to "feel" the inner surface and also have a feeling when the probing tip 114 actually contacts the bottom of the hole, but the strain sensor 146 may also generate an electronic signal based on the sensed strain on the shaft 110, which may then be used to provide the surgeon via the device 148 (i.e., speaker or light) an audible and / or visual alert indicating that the probing tip 116 has effectively been positioned at the bottom of the hole.

[0060] For example, the resistance experienced when the probing tip 116 engages the bottom of the hole may have a certain strain value (i.e., above a certain threshold) that may be different from the resistance experienced with the sidewall of the hole (which may have a softer and more spongy tissue). Thus, an audible and / or visual alert may allow the surgeon to ascertain whether they have, in fact, positioned at the bottom of the hole, or whether too much pressure is being applied against the interior surface such that they are at risk of potentially unintentionally puncturing the interior surface.

[0061] 12A-12F illustrate a sequence of steps for performing a procedure to probe a drilled hole and subsequently obtain depth measurements using another embodiment of a medical device 300 consistent with the present disclosure. As shown, the device 300 may be similarly configured as the device 100 described herein above. However, as shown in FIG. 12E, the bone probe 108 and the depth gauge member 116 may both be fully retracted into the handle 102, as shown in FIG. 12A, until either the first slider 324 is moved, resulting in a corresponding movement of the bone probe 108, or the second slider 350 is moved, resulting in a corresponding movement of the depth gauge member 116.

[0062] In addition to including a slider for allowing independent movement of the bone probe and the depth gauge member, the device 300 further includes a locking member 352 for locking the position of at least the bone probe 108. As shown, the locking member 352 is coupled to the first end 104 of the handle 102 and is associated with at least the bone probe 108 in a manner such as to allow / prevent movement of the bone probe 108. For example, the locking member 352 has an unlocked configuration and a locked configuration, where in the unlocked configuration the locking member 352 allows the bone probe 108 to move freely and in the locked configuration the locking member 352 prevents movement of the bone probe 108.

[0063] For example, in response to extending the bone probe 108, the surgeon may then place the locking member 352 in a locked configuration, as shown in FIG 12C, where the locking member 352 is configured to provide sufficient contact with the bone probe shaft 110 to prevent or make difficult movement of the bone probe shaft 110 relative to the first end 104 of the handle 102, thereby providing a amount of stiffness to the probe shaft 110. Thus, the surgeon may now perform inspection of the drilled hole without concern that the bone probe 108 will be pulled back or come loose within the handle 102.

[0064] Upon locating the base or bottom of the hole, the surgeon may then apply sufficient force on the bone probe shaft 110 such that the engagement surface of the second portion of the probe tip engages and establishes a hook with the side wall at or immediately adjacent to the bottom of the hole, as shown in FIG. 12D. Upon establishing the engagement, the surgeon may then place the locking member 352 in an unlocked configuration, where the bone probe shaft 110 is in a stabilized position. The surgeon may then move the handle in a direction toward the bone until the first end of the handle abuts the surface of the bone or the surface of the plate / implant, as shown in FIG. 12E, at which point the depth gauge member 116 can be used to measure the depth of the hole. As shown in FIGURE 12F, the surgeon may then advance the depth gauge member 116 towards the hole via the second slider 350 such that the distal end 120 of the depth gauge member shaft 118 extends from the first end of the handle of the device and advances into the hole and slides over the bone probe 108. The bone probe 108 is maintained in engagement with the bottom of the hole via the probing tip, while the depth gauge member may be advanced in a direction towards the bottom of the hole until the distal end of the depth gauge member contacts the bottom of the hole. The bone probe essentially acts as a guide over which the depth gauge member slides as it advances to the bottom of the hole.

[0065] The sensor is configured to generate an electronic signal based on the distance between the first end of the body and the distal end of the depth gauge member, the electronic signal being indicative of at least the depth of the hole. In particular, the sensor may include an inductive or capacitive element or assembly configured to sense the location of the distal end of the depth gauge member relative to the first end of the device body, and, as a result, generate an electronic signal representative of the distance therebetween. Thus, the distance sensed between the first end of the device handle (when abutting the bone surface) and the distal end of the depth gauge member (when abutting the bottom of the hole) is the depth of the hole.

[0066] It should be noted that the device may include logic or allow adjustments to the sensing capabilities to program the sensor to take other variables into account when sensing the depth of the hole. For example, in some embodiments, a procedure requires a plate or implant to be fixed to the bone via a screw. Thus, the length of the screw must not only be long enough to fill the hole, but also long enough to take into account the thickness of the plate or implant it passes through when engaging the hole. Thus, in some embodiments, the sensor may be programmed to take into account the thickness of the plate or implant, and will include that thickness in the electronic signal that is produced to indicate the total depth that the corresponding screw length will need to cover, including the depth of the hole in the bone, in addition to the thickness of the plate or implant through which the screw will pass and into which the screw head will engage.

[0067] Additionally, in some cases, the first end of the handle of the device will be directly against the surface of the plate or implant that is directly against the surface of the bone when the surgeon is measuring the depth, as shown in Figure 12F. Thus, in this case, the sensor would still be able to sense the distance between the first end of the handle of the device and the distal end of the depth gauge member, which would provide the overall depth, not just the depth of the hole in the bone.

[0068] 13A-13C illustrate a series of steps for performing a procedure in which a bone probe 208 is used to probe a fully drilled hole (i.e., a hole that extends completely through the bone for receipt of a bi-cortical bone screw) and further establishes an engagement of the probing tip 212 of the bone probe 208 with the side of the bone adjacent the bi-cortical drill hole, securing the bone probe 208 in place, and enabling the depth gauge member to be used to measure the depth of the bi-cortical drill hole. It is noted that the bone probe 208 of FIGS. 4-9 is compatible for use with any of devices 100 and 300, and may be extended, retracted, and otherwise manipulated for subsequent probing and depth measurements therefrom in a manner similar to the bone probe 108 described previously herein.

[0069] As shown in Figures 13A-13C, the hole is drilled completely through the bone (i.e., a bicortical drill hole), and therefore the surgeon will need to not only explore the inner surface of the hole, but also potentially obtain nerve monitoring data (i.e., determine whether there are any nearby nerves that may be affected by the placement of the screw in the hole), as well as obtain an accurate measurement of the depth of the entire hole.

[0070] As shown in FIG. 13A, the surgeon may first perform an inspection of the drilled hole with the probing tip 214 by advancing the bone probe 208 into the drilled hole. The surgeon may simply apply slight pressure so that the base portion 220 of the probing tip 214 contacts the interior surface of the hole and in return provides the surgeon with tactile feedback of the interior surface. The base portion 220 is shaped to slide or easily glide along the interior surface while still allowing sufficient contact to provide tactile feedback to the surgeon. The surgeon may then advance the probing tip 214 completely through the hole, at which point the base portion 220 will cease contacting the interior surface and the surgeon will sense (via tactile feedback) that the end of the hole has been reached (shown in FIG. 13B).

[0071] At this point, in response to the surgeon extending the probing tip 214 completely through the bicortical drill hole, the surgeon can then establish a hook between the top portion 222 of the probing tip 214 and a portion of the opposing side of the bone to secure the bone probe shaft 210 in place for subsequent depth measurements with a depth gauge member. For example, as shown in FIG. 13C, the surgeon may simply position the generally planar second side 218 against the interior surface of the drilled hole and then retract (i.e., pull back) the probe shaft 210 such that the engagement surface 226 of the top portion 222 of the probing tip 214 contacts a portion of the opposing side of the bone directly adjacent the opening of the hole. The engagement surface 226 may be a generally abrupt edge (e.g., a sharp corner or edge) of the probing tip 214 where the transition between the base portion 220 and the top portion 222 is abrupt. Thus, as the surgeon pulls the bone probe shaft 210 back towards the hole, the engagement surface 226 will begin to contact the bone. In some embodiments, the engagement surface 226 may include surface texturing to improve friction between the engagement surface 226 and a portion of the bone and reduce the risk of slippage during bicortical depth measurements. Additionally, the groove 224 (present at the junction between the distal end 212 of the probe shaft 210 and the probing tip 214) allows additional flexing of the probing tip 214 relative to the remainder of the probe shaft 210 due to less material at the junction between the shaft 210 and the tip 214 at the groove 224, which will improve the hooking or gripping of the engagement surface 226 of the top portion 222 of the probing tip with the opposing side of the bone. Additionally, the tapered thickness of the shaft 210 provided by the generally planar second side 218 allows for deflection or flexion of the shaft 210 on one axis such that when the feeling tip 214 is generally perpendicular to the shaft 210, as generally shown, application of pressure on the shaft 210 causes deflection of the feeling tip 214, and in particular the engagement surface 226, to become angled upwardly, thereby allowing for better hooking or gripping of the exterior surface of the opposing side of the bone. Upon securing the bone probe 208 in place, depth measurements can occur using a depth gauge member in a manner similar to that of the bone probe 108 described previously herein.

[0072] 14 is another embodiment of a medical device 400 consistent with the present disclosure having a display 454 for providing a digital readout of the borehole depth measurement based on the electronic signal from the sensor. The display 454 may include, for example, a liquid crystal display or an LED display.

[0073] 15 is another embodiment of a medical device 500 consistent with the present disclosure configured to wirelessly communicate and transmit depth measurement data over a network to a wireless computing device 600 for recording, storing, and / or visually displaying the measured depth based on the electronic signal from the sensor to determine the depth of the drilled hole. For example, the device 500 may include at least a wireless display or computing device 600 for visually providing the hole depth measurement based on the electronic signal from the sensor, and a wireless transmitter 556 configured to wirelessly communicate and exchange information including electronic signals. The separate display or computing device 600 may include, but is not limited to, a monitor or panel display, a PC, a notebook, a tablet computer, a smartphone, or other computing device configured to wirelessly communicate with the wireless transmitter 556.

[0074] The network may be any network that carries data. Non-limiting examples of suitable networks that may be used as the network may include WiFi wireless data communication technology, the Internet, a private network, a virtual private network (VPN), a public switched telephone network (PSTN), an integrated services digital network (ISDN), a digital subscriber link network (DSL), various second generation (2G), third generation (3G), and fourth generation (4G) cellular-based data communication technologies, Bluetooth® wireless, near field communication (NFC), the latest release of the IEEE 802.11 transmission protocol standard, and other networks capable of carrying data and combinations thereof.

[0075] Further, in some embodiments, the computing device 600 may include specific software applications that may be instructed to maintain a record of hole measurements and / or provide an interactive user interface (GUI) in which multiple holes may be mapped to a particular plate or implant and the depth of each hole (including the thickness of the plate or implant) may be included and stored for recording.

[0076] 16 and 17 illustrate the compatibility of the medical device of the present disclosure with other medical devices to provide additional features such as energy emission (FIG. 16) and sensing capabilities (FIG. 17) for additional bone exploration and depth measurement. For example, in some embodiments, the bone probe shaft 110, 210 may comprise a conductive material (e.g., a metal such as stainless steel, nitinol, or aluminum), and a portion of the bone probe shaft 110, 210 may be exposed or otherwise accessible along a portion of the handle of the device. In particular, the handle of the device may include an access area 158, which may be in the form of an opening, window, or the like, that provides access to the interior of the handle, and in particular, to the exposed portion of the bone probe shaft. Thus, in some embodiments, electrical current from a separate device 700, 800 may be supplied to the bone probe shaft via the access area 158 (e.g., sliding the working tip 702 of the electrocautery device 700 into the access area 158 so as to contact the bone probe shaft 110, 210). Thus, as a result of being made from a conductive material, the bone probe shaft 110, 210 may carry electrical current to the distal probe tip which may then be used to deliver energy to a desired target (e.g., the interior surface of a hole in a bone) as a result of an electrical current applied thereto. Similarly, a separate neural sensing / stimulation device 800 (shown in FIG. 17) may be coupled to the conductive bone probe shaft through the access region (i.e., sliding the working tip 802 of the device 800 into the access region 158) such that the distal probe tip essentially acts as an extension to the neural sensing / stimulation device and may be used to sense / stimulate nerves in the bone. The separate sensing / neural stimulation device or system 800 may include, for example, existing capital equipment or a handheld battery-powered neural monitoring device.

[0077] FIG. 18 is a perspective view of the medical device 100 having a port 160 provided on the proximal, or second, end 106 of the device body 102. The port 160 is configured to receive a corresponding input connector from a neural sensing / neurostimulation device 800. The port 160 (hereinafter referred to as the "neural monitoring port 160") is coupled to the bone probe shaft 110, 210 and configured to provide an electrical pathway from the neural sensing / neurostimulation device 700 to the bone probe 108, 208 upon insertion of the input connector into the neural monitoring port 160. As previously described, the bone probe shaft 110, 210 may include an electrically conductive material (e.g., a metal such as stainless steel, nitinol, or aluminum) and thus may carry an electrical signal. Thus, in some embodiments, an electronic signal from the neural sensing / neurostimulation device 800 may be provided to the bone probe shaft 110, 210 via the neural monitoring port 160. Thus, as a result of being made from a conductive material, the bone probe shaft 110, 210 may then carry an electrical signal to the distal probe tip 114, 214 which may be used to sense / stimulate nerves adjacent or in close proximity to a hole drilled in the bone, either when the bone probe 108, 208 is placed directly into a drilled hole or when the bone probe 108, 208 contacts a screw placed into the drilled hole.

[0078] 19 is a side view of the medical device 100 of FIG. 18 illustrating, in partial cross section, the configuration of the bone probe shaft 110 for carrying electrical signals to and from the neural sensing / stimulation device. It is noted that the bone probe shaft 210 is also compatible with the neural sensing / stimulation device and may function in a manner similar to the bone probe shaft 110 described herein. Upon insertion of the electrical connector into the neural monitoring port 160, a pathway is provided between the neural sensing / stimulation device 700 and the bone probe 108. The bone probe shaft 108 generally includes a flexible coil portion 162 configured to allow conduction of electrical signals provided by the neural sensing / stimulation device 800, while the shaft 110 moves between a fully retracted position, a fully extended position, and intermediate positions therebetween, particularly when measuring the depth of the drilled hole 134. In some embodiments, a portion of the distal end 112 of the bone probe 108, particularly the exposed portion of the shaft 110 that is extendable outside the device body 102, may include insulating material 164, while the distal exploration center 114 does not include insulating material.

[0079] 20A, 20B, and 20C illustrate the transmission of signals from the bone probe 108 to a screw positioned in a hole in the spine for neuromonitoring capabilities. As shown in FIG. 20A, upon coupling the neurosensing / neurostimulation device 700 to the medical device 100 (e.g., inserting an electrical connector into the neuromonitoring port 160), the surgeon can begin a neuromonitoring procedure to determine whether there are any critical neural structures adjacent to or within dangerous proximity of the drilled hole and screw. In particular, the surgeon can perform a neuromonitoring procedure by placing the bone probe 108 directly in the drilled hole prior to the placement of the screw, where the distal probing tip 114 is placed in direct contact with the interior of the hole and can transmit electrical signals from the neurosensing / neurostimulation device 800 to the bone tissue, followed by receiving a response signal that will then be carried back to the neurosensing / neurostimulation device 700 for processing. Alternatively, as shown in FIGS. 20A, 20B, and 20C, the surgeon performs the neuromonitoring procedure by placing the distal probing tip 114 in direct contact with the screw, which will then act as a conduit and carry electrical signals to and from the distal probing tip 114 and the neurosensing / neurostimulation device 900 once the screw is already in place (e.g., fitted into an already drilled hole).

[0080] Thus, the medical device consistent with the present disclosure is a three-in-one, single-use device designed to more accurately and safely measure screw hole trajectories. For example, the probing tip of the bone probe provides the user (e.g., surgeon) with excellent tactile feedback to assist the surgeon in confirming a safe path within the bone. Electronic measurement / digital sensing is designed to provide more accurate depth measurements for the screw trajectory. Neuro-monitoring features are used to stimulate the trajectory and / or screw to ensure that the screw is safely positioned away from any critical neural structures. Overall, the medical device of the present disclosure is a faster, safer, more accurate, and user-friendly solution for surgeons when placing bone screws, particularly pedicle screws during spinal fusion surgery, thereby minimizing spinal surgery complications and reducing overall medical costs.

[0081] 21 illustrates an angle guide 900 for use with the medical devices of the present disclosure. In some cases, a hole may be drilled into a bone at an angle. Thus, the angle guide can be useful in providing the surgeon with a visual guide as to the correct angle to position the device when inspecting the hole and also attempting to locate the bottom of the hole and take a depth measurement.

[0082] FIG. 22 is a perspective view of another embodiment of a medical device 1000 consistent with the present disclosure. FIG. 23 is a perspective exploded view of the medical device 1000. The device 1000 is configured to provide faster and more accurate measurements of depth. In particular, the device 1000 includes a combination of a bone probe that allows for physical inspection of a hole drilled in a bone and a depth gauge member for determining the depth of the hole and providing a digital measurement of the depth. The device 1000 generally includes a handle 1002 including a bone probe secured thereto, a depth gauge cylinder 1004 slidably mounted over a portion of the handle 1002 and configured to slide along its length, and a tip member 1006 releasably coupled to a distal end of the depth gauge cylinder 1004. As shown, the bone probe may generally include a bone probe 208, as previously described herein with respect to at least FIGS. 4-9. The device 1000 further includes at least a user-operated activation mechanism 1008 (which may be in the form of a button or other actuable input mechanism) that may activate and deactivate the depth measurement function as well as other functions of the device 1000. As shown, the device 1000 further includes a display 1010, provided on the handle 1002, configured to visually provide a digital readout of the depth measurement of the hole in the bone.

[0083] As shown, the depth gauge cylinder 1004 includes a hollow body including a lumen within which the handle 1002 and at least a portion of the bone probe 208 are received. In particular, the handle 1002 may include an extension 1012 extending generally from a proximal grip of the handle 1002. The depth gauge cylinder 1004 is operable to slide along a longitudinal axis of the handle body 1012 from an initial default position (a proximal-most position relative to the grip of the handle 1002) to a distal-most position (relative to the grip of the handle 1002) and multiple positions therebetween, as shown in FIG. 22. As further shown, the depth gauge cylinder 1004 comprises a one-piece, unitary construction. The tip member 1006 further comprises a one-piece, unitary construction. Thus, the depth gauge cylinder 1004 and tip member 1006 provide a much more rigid and durable design compared to currently available depth measurement devices that rely on a two-piece construction. In particular, the one-piece cylindrical body of the depth gauge cylinder and tip member obviates the problems faced by the present devices, among others, of splitting a two-piece handle when an associated bone probe is pivoted within a hole and applies pressure to the handle.

[0084] The tip member 1006 is releasably coupled to the distal end of the depth gauge cylinder 1004, which may include a threaded engagement type coupling (i.e., the tip member 1006 may be threaded onto the distal end of the depth gauge cylinder 1004), a snap-fit ​​coupling, an interference fit coupling, or the like. Once coupled to the depth gauge cylinder 1004, the tip member 1006 is operable to slide correspondingly with the depth gauge cylinder 1004. The tip member 1006 further includes an opening through which at least the bone probe 208 is received and travels during movement of the tip member 1006 and the depth gauge cylinder 1004. The tip member 1006 further comprises a distal end including a contour corresponding to an opening in a bone plate through which a screw is to be received, as will be described in more detail herein. In particular, as described in more detail herein, the tip member may be considered versatile in that the profile may enable the tip member 1006 to precisely and accurately fit the majority of shapes, sizes, and geometries of screw sockets and openings in bone plates. Note that the distal end of the depth gauge cylinder 1004 is operable to receive and releasably retain one of a number of interchangeable tip members. Thus, the tip member may be interchangeable with any number of tip members, each having a different size, shape, geometry, profile, or the like, depending on the particular implant or bone plate to be used. Thus, only the tip member needs to be changed while the remainder of the device is sufficient for the intended procedure.

[0085] The device 1000 further includes a sensor configured to generate an electronic signal indicative of the depth of the hole, the electronic signal varying in relation to the distance traveled by the depth gauge cylinder 1004 relative to the handle 1002 and bone probe 208. In particular, the sensor may include an inductive or capacitive element or assembly configured to sense the location of the distal end of the depth gauge cylinder 1004 relative to a specific point along the handle body 1012, for example, and to generate an electronic signal representative of the distance therebetween as a result of the movement (i.e., sliding) of the depth gauge cylinder 1004. The sensor communicates with depth gauge electronics and / or circuitry provided on a printed circuit board (PCB) (not shown), which may be provided within the depth gauge cylinder 1004. For example, the inductive or capacitive element may include a resistive stripe within the depth gauge cylinder 1004, while a copper brush spring 1016 may be provided (held in place via a protrusion 114) along a portion of the handle body 112. The spring 1016 may provide a form of friction with the depth gauge cylinder 1004 .

[0086] FIG. 24 is a top view of the medical device 1000 illustrating the depth gauge cylinder 1004 in an initial default position relative to the handle 1002 and bone probe 208. FIG. 25 is a cross-sectional view of the medical device 1000 taken along line 25-25 of FIG. 24. FIG. 26 is a side view of the medical device of FIG. 22. A dowel pin 1018 may be provided that extends through at least a portion of the depth gauge cylinder 1004 as shown in FIG. 25 and engages a portion of the handle body 1012 to help retain the depth gauge cylinder 1004 and the handle body 1012 relative to one another (i.e., prevents the depth gauge cylinder 1004 from sliding completely out of the handle body 1012 as it moves toward the bone probe tip).

[0087] 27 is a perspective view of the medical device 1000 illustrating the movement of the depth gauge cylinder 1004 relative to the handle 1002 and bone probe 208. As will be described in more detail herein, the sensor is configured to generate an electronic signal based on the distance the depth gauge cylinder 1004 travels relative to the handle 1002 and bone probe 208, the electronic signal being indicative of at least the depth of the hole. In particular, the sensor may include an inductive or capacitive element or assembly configured to sense, for example, the location of the distal end of the depth gauge cylinder 1004 relative to a particular point along the handle body 112, and to generate an electronic signal representative of the distance therebetween as a result of the movement (i.e., sliding) of the depth gauge cylinder 1004. For example, the depth gauge cylinder may generally slide between a proximal-most position, a distal-most position, and multiple positions therebetween, relative to the handle and bone probe. Thus, the depth gauge cylinder may be in a proximal-most position when in a default initial position when no depth measurement has been initiated, as will be described in more detail herein, and upon progressing a distance from the initial default position (i.e., the proximal-most position), the distance progressed is then used to determine the depth of the hole that has undergone a depth measurement using device 1000.

[0088] FIG. 28 is a perspective view of another embodiment of the medical device 1000 of FIG. 22 illustrating a user-operated control mechanism 1008 provided on the handle 1002 as opposed to the depth gauge cylinder 1004.

[0089] 29A, 29B, and 29C are enlarged side views of the tip member 1006 illustrating stepped profiles of various dimensions. As previously explained, the tip member 1006 includes a distal end that includes a profile corresponding to an opening in a bone plate through which a screw will be received. More specifically, the tip member 1006 of the present disclosure is particularly useful in procedures in which depth measurements are to be taken with the bone plate in place (i.e., positioned where it will be mounted). As is generally understood, it is preferable to countersink the screw when performing a bone implant fixation procedure to avoid any potential complications as a result of the screw head extending from the bone surface or bone plate. In bone plate holes (for receiving screws), there are known general geometries of countersinks, including at least tiny, small, and large fragments, with tiny fragments being the most common. The profile of the distal end of the tip member 1006 comprises a stepped profile including a plurality of distinctly different discrete stepped sections, each having a different diameter (as illustrated in FIGS. 29A, 29B, and 29C) that gradually decreases in diameter from a proximal location on the tip member to a distal location of the tip member. Each discrete stepped section has an individual shape and / or diameter that corresponds to the shape and / or diameter of a common countersink size provided in a bone plate. Thus, the tip member 1006 may be considered versatile in that the profile may enable the tip member 1006 to precisely and accurately fit into the majority of shapes, sizes, and geometries of screw sockets and openings in bone plates. For example, the diameter in each stepped section may correspond to the diameter of one of the typical geometries of a countersink (e.g., a first diameter corresponds to a large fragment, a second diameter corresponds to a small fragment, a third diameter corresponds to a very small fragment, etc.).

[0090] FIG. 30 is a side view of another embodiment of a medical device 1000a including a unitary body construct, and FIG. 31 is an enlarged side view of tip member 1006 illustrating various dimensions of tip member profiles.

[0091] 32 and 33 illustrate a customized grip on a portion of another medical device 1100 consistent with the present disclosure, in a perspective view thereof. In particular, the medical device 1100 is similar in features to the medical device 1000, and thus like features include like reference numbers. For example, the medical device 1100 includes a handle 1102 including a bone probe 208 secured thereto, a portion of the handle 1102, specifically a depth gauge cylinder 1104 slidably mounted across and configured to slide along the length of the handle body 1112, and a tip member 1106 releasably coupled to a distal end of the depth gauge cylinder 1104. The device 1100 further includes a display 1110 provided on the handle 1102 configured to visually provide a digital readout of the depth measurement of the hole in the bone. The device 1100 may further include gripping portions 1105a, 1105b provided on the depth gauge cylinder 1104 that may provide improved grip for the operator during the procedure, especially during a depth measurement procedure.

[0092] FIG. 34 is a perspective exploded view of another embodiment of a medical device 1200 consistent with the present disclosure. FIG. 35 is a perspective view of the medical device 1200 in an assembled state. The medical device 1100 is similar in features to the medical device 1000, and thus like features include like reference numbers. For example, the medical device 1200 includes a handle 1202 including a bone probe 208 secured thereto, a depth gauge cylinder 1204 slidably mounted across and configured to slide along a length of a portion of the handle 1202, specifically the handle body 1212, and a tip member 1206 releasably coupled to a distal end of the depth gauge cylinder 1204. The tip member 1206 may further include radiopaque and / or echogenic markings and thus may be visible under various medical imaging procedures, including, but not limited to, fluoroscopy, direct visualization, and ultrasound (e.g., endoscopic ultrasound). For example, as shown, the tip member 1206 may include a radiopaque ring 1207 proximate its distal end.

[0093] The device 1200 further includes a display 1210 provided on the handle 1202 configured to visually provide a digital readout of the depth measurement of the hole in the bone. As shown, the depth gauge cylinder 1204 may slide generally along a track 1213 or rail assembly defined along the handle body 1212 that generally corresponds to a portion 1205 of the depth gauge cylinder 1204. The depth gauge cylinder 1204 may further include an exterior surface with a plurality of gripping portions defined thereon. The gripping portions may be either protrusions or recesses that are either formed within the body of the depth gauge member 1204 or comprised of a separate material.

[0094] 36 is a top view of the medical device 1200 illustrating the depth gauge cylinder 1204 in a distal-most position relative to the handle 1202 and bone probe 208. FIG. 37 is a cross-sectional view of the medical device 1200 taken along line 37-37 of FIG. 36. FIG. 38 is a side view of the medical device 1200. A set screw 1218 may be provided that extends through at least a portion of the depth gauge cylinder 1204 as shown in FIG. 25 and engages a portion of the handle body 1212 to help retain the depth gauge cylinder 1204 and the handle body 1212 relative to one another (i.e., prevents the depth gauge cylinder 1204 from sliding completely out of the handle body 1212 as it moves toward the bone probe tip).

[0095] 39 is a perspective view of another embodiment of a medical device 1300 consistent with the present disclosure. FIG. 40 is a perspective exploded view of the medical device 1300. Although the medical device 1300 may share similarities in function with the medical device 1000, the medical device 1300 is generally arranged in a different manner than the medical devices 1000, 1100, and 1200 previously described herein. For example, as shown, the medical device 1300 includes a portion of the handle 1302 that includes a bone probe 208 secured thereto, a portion of the handle 1302, specifically a depth gauge cylinder 1304 that generally forms a majority of the device 1300 that is slidably mounted across and configured to slide along the length of the handle body, and a tip member 1306 that is releasably coupled to a distal end of the depth gauge cylinder 1304. The tip member 1306 may further include a radiopaque ring 1307 on the distal end.

[0096] The device 1300 further includes a display 1314 provided on the depth gauge cylinder 1304 configured to visually provide a digital readout of the depth measurement of the hole in the bone. As shown, the depth gauge cylinder 1304 includes an elongated hollow body that forms the majority of the device 1300, with a portion of the handle 1302 positioned along the underside of the depth gauge cylinder 1304. The device 1300 further includes a retaining cap 1308 for covering an open proximal end of the depth gauge cylinder 1304. The depth gauge cylinder 1304 further includes a repositionable thumb rest 1310 along the upper side of the depth gauge cylinder 1304. The thumb rest 1310 may be repositioned to various positions along the length of the depth gauge cylinder 1304 via a retaining tab 1312.

[0097] Fig. 41 is a top view of the medical device 1300 illustrating the depth gauge cylinder 1304 in an initial default position relative to the handle 1302 and bone probe 208. Fig. 42 is a cross-sectional view of the medical device taken along line 42-42 of Fig. 41. Fig. 43 is a side view of the medical device 1300.

[0098] 44A-44E illustrate a series of steps for using an embodiment of a medical device, such as medical device 1000, consistent with the present disclosure to perform a procedure with a bone probe (similar to the bone probe of FIG. 4) to probe a fully drilled hole (i.e., a hole extending completely through the bone for receipt of a bi-cortical bone screw), further establishing a hook between the probing tip of the bone probe and the side of the bone adjacent the bi-cortical drill hole to secure the bone probe in place, and subsequently obtaining depth measurements.

[0099] As shown, the holes are drilled completely through the bone (i.e., bicortical drill holes), so the surgeon would need to not only probe the interior surface of the hole, but also obtain an accurate measurement of the entire hole depth. Additionally, a bone plate is positioned on the bone, which would require a tool to determine the hole depth while taking into account the thickness of the bone plate.

[0100] As shown in FIG. 44A, the surgeon may first perform an inspection of the drilled hole with the probing tip 214 by advancing the bone probe 208 into the drilled hole. The surgeon may simply apply slight pressure so that the base portion of the probing tip contacts the interior surface of the hole and in return provides tactile feedback of the interior surface to the surgeon. The base portion is shaped to glide or easily slide along the interior surface while still allowing sufficient contact to provide tactile feedback to the surgeon. The surgeon may then advance the probing tip 214 completely through the hole, at which point the base portion will cease to contact the interior surface and the surgeon will sense (via tactile feedback) that the end of the hole has been reached (shown in FIG. 44B).

[0101] At this point, in response to the surgeon extending the probing tip 214 completely through the bicortical drill hole, the surgeon can then establish a hook between the top portion of the probing tip 214 and a portion of the opposing side of the bone to secure the bone probe shaft 210 in place for subsequent depth measurements with the depth gauge cylinder 1004 and tip member 1006. For example, as shown in FIG. 44C, the surgeon may simply position the generally planar second side of the bone probe tip against the interior surface of the drilled hole and then retract (i.e., pull back) the probe shaft 210 such that the engagement surface of the top portion of the probing tip 214 contacts a portion of the opposing side of the bone directly adjacent the opening of the hole. The engagement surface may be a generally abrupt edge (e.g., a sharp corner or edge) of the probing tip 214 where the transition between the base portion and the top portion is abrupt. Thus, as the surgeon pulls the bone probe shaft 210 back toward the hole, the engagement surface will begin to contact the bone. Upon securing the bone probe 208 in place, depth measurements can occur using the depth gauge cylinder 1004 and tip member 1006 .

[0102] For example, with reference to medical device 1000, bone probe 208 is generally secured to a handle 1002 of device 1000. Handle 1002 may include a proximal end including a gripping portion, for example, to provide a surgeon with a means for applying a withdrawal force to withdraw an engagement surface of a probing tip of the bone probe into engagement with an exterior surface of the bone immediately adjacent a bicortical foramen in the bone.

[0103] Thus, upon establishing a hook with the outer surface of the bone and generally providing an edge for the exit point of the drilled portion (or otherwise drilled hole) through the probe tip, the surgeon need only continue to pull back on the handle, thereby maintaining engagement of the bone probe with the outer surface of the bone, as illustrated in FIG. 44D, and then slide the depth gauge cylinder 1004 in a direction toward the bone.

[0104] As illustrated in FIG. 44E, in response to sliding the depth gauge member 1004 toward the bone, at least a portion of the tip member 1006 will pass through an opening in the bone plate corresponding to the drilled hole until a portion of the stepped profile of the tip member 1006 contacts and engages with a countersink portion of the opening in the bone plate. When the tip member 1006 is correctly positioned in the countersink of the bone plate, the distal-most edge of the tip member 1006 will be aligned along the same plane as the bone-facing surface of the bone plate. For example, as described above, the tip member 1006 includes a distal end that includes a profile that corresponds to the opening in the bone plate through which the screw will be received. More specifically, the tip member 1006 of the present disclosure is particularly useful in procedures in which depth measurements are to be taken with the bone plate in place (i.e., positioned where it will be mounted). As is generally understood, it is preferred to countersink the screw when performing a bone implant fixation procedure to avoid any potential complications as a result of the screw head extending from the bone surface or bone plate. In bone plate holes (for receiving screws), there are known common geometric shapes of countersinks, including at least extra small, small, and large segments, with extra small segments being the most common. The profile of the distal end of the tip member 1006 comprises a stepped profile including a plurality of distinctly different discrete stepped portions, each having a different diameter (as illustrated in FIGS. 29A, 29B, and 29C) that gradually decreases in diameter from a proximal position on the tip member to a distal position of the tip member. Each discrete stepped portion has a distinct shape and / or diameter that corresponds to the shape and / or diameter of a common countersink size provided in a bone plate. Thus, the tip member 1006 may be considered versatile in that the geometry may enable the tip member 1006 to precisely and accurately fit most shapes, sizes, and geometries of screw sockets and openings in bone plates. For example, the diameter at each stepped portion may correspond to the diameter of one of the typical geometries of a countersink (e.g., a first diameter corresponds to a large fragment, a second diameter corresponds to a small fragment, a third diameter corresponds to an extra small fragment, etc.).

[0105] The sensor is then configured to generate an electronic signal based on the distance the depth gauge cylinder 1004 has advanced relative to the handle and the bone probe, the electronic signal being indicative of at least the depth of the hole. In particular, the sensor may include an inductive or capacitive element or assembly configured to sense the location of the distal end of the depth gauge cylinder relative to a particular point along the handle, and to generate an electronic signal representative of the distance therebetween as a result of the movement (i.e., sliding) of the depth gauge cylinder. For example, the depth gauge cylinder may generally slide between a proximal-most position, a distal-most position, and multiple positions therebetween, relative to the handle and the bone probe. Thus, the depth gauge cylinder may be in a proximal-most position when in a default initial position when depth measurement has not yet been initiated. In response to establishing engagement between the bone probe tip and the bone, the depth gauge cylinder may then be advanced from the default initial position in a direction toward the bone until the tip member, specifically the stepped profile, contacts the countersink in the bone plate opening. The sensed distance traveled by the depth gauge cylinder is then used to calculate the hole depth. In particular, the device may include logic for determining the hole depth based on known variables. For example, the length of the bone probe shaft extending from the distal end of the tip member when the depth gauge cylinder is in an initial default position (i.e., the most proximal position relative to the handle) may be known and programmed into the logic. Thus, the sensed distance traveled by the depth gauge cylinder from the initial default position until the tip member, specifically the stepped profile, contacts the countersink in the bone plate opening may simply be subtracted from the known length of the bone probe shaft, thereby providing the hole depth.

[0106] 45 and 46 are perspective views of another embodiment of a medical device 4500 consistent with this disclosure. The medical device 4500 includes a handle 4510 with a bone probe 208. The medical device 4500 further includes a depth gauge cylinder 4520 slidably mounted over a portion of the handle 4510, and in particular, a handle body 4530 shaped to be received by the depth gauge cylinder 4520. The depth gauge cylinder 4520 is configured to slide along the length of the handle 4530 between a proximal-most position (depicted by FIG. 45), a distal-most position (depicted by FIG. 46), and multiple positions therebetween. At the proximal-most position, the bone probe 208 is maximally exposed and the proximal end of the depth gauge cylinder 4520 abuts the portion of the handle that includes the display. When the depth gauge cylinder 4520 is slid to its distal-most position, the bone probe 208 is minimally exposed, even though the interlock assembly (discussed below) of the depth gauge cylinder 4520 and handle 4510 are interlocked to prevent the depth gauge cylinder 4520 from sliding off the handle body 4530, the interlock assembly thereby establishing the distal-most position.

[0107] In an embodiment, the medical device comprises a handle body 4530 that is generally cylindrical. The handle body 4530 may comprise a rigid material, such as plastic, and may be shaped to be received by the depth gauge cylinder 4520 and provide a surface over which the depth gauge cylinder 4520 may slide. As discussed below, the cylindrical handle body 4530 is further configured to prevent a user's hand or fingers from contacting a sensor, which is at least partially enclosed within the handle body 4530, during operation.

[0108] 47 is an exploded view of the medical device 4500 shown in FIGS. 45 and 46. The medical device 4500 includes a handle 4510 with a two-piece construction. The two-piece construction of the handle 4510 includes a first body member 4000 coupled to a second body member 4010, the first body member 4000 defining approximately a first half of the handle 4510 and the second body member 4010 defining a corresponding second half of the handle 4510 relative to a median plane that bisects the medical device 4500 along its longitudinal axis. The first and second body members 4000, 4010 may be coupled together by tabs or protrusions, such as interference fit or snap-fit ​​tabs, or other similar fasteners.

[0109] At least partially enclosed by the first and second body members 4000, 4010 is a sensor 4020. The sensor 4020 is configured to determine a position of the depth gauge cylinder 4520 along the length of the handle body 4530 during operation. The position of the depth gauge cylinder 4520 is determined by the sensor 4020 based, at least in part, on a contact point made by a member 4030 protruding from an interior surface of the depth gauge cylinder 4520, the member 4030 being biased to exert a pressure on the sensor 4020. For example, when the depth gauge cylinder 4520 is in a proximal-most position along the handle body 4530, the contact point made by the member 4030 is at a proximal position on the sensor 4020.

[0110] When the depth gauge cylinder 4520 is slid to its distal-most position, the contact point made by the member 4030 is at a distal position of the sensor 4020, etc., such that the sensor 4020 is configured to detect each position of the depth gauge cylinder 4520 along the handle body 4530 between and including the proximal-most and distal-most positions. The member 4030 may be fastened, molded, or fixed to an interior surface of the depth gauge cylinder 4520. The member may, for example, comprise a protrusion or tab, such as a tab in the shape of a wiper arm, or may comprise one of a ball and spring plunger, a ball detent, or other similar mechanical arrangement.

[0111] The sensor 4020 comprises a pressure sensitive strip 4100 that is sensitive to contact by the member 4030 based on an applied force or pressure. The sensor 4020 generates a signal as a function of the location of the contact based on where the force and / or pressure is applied along the pressure sensitive strip 4100. The sensor 4020 may comprise a pressure sensitive strip, such as those sold under the trade names of Tescan Inc. or SpectraSensor. The pressure sensitive strip 4100 may comprise a width of approximately 2 mm to 7 mm. The pressure sensitive strip 4100 may comprise a length of approximately 25 mm to 100 mm. The pressure sensitive strip 4100 may be configured to detect a force within a range of approximately 0.05 N to 5 N.

[0112] The sensor 4020 may be operatively coupled to a printed circuit board (PCB) that constitutes a processor 4040 and / or other digital electronic device that functions to produce an output for an electronic display 4050, such as a liquid crystal display. The output relates to a measurement of the depth of the hole drilled into the bone, as described above. The measurement is determined by the distance traveled by the depth gauge cylinder 4520 relative to the handle 4510. More specifically, the measurement may be based, at least in part, on a comparison between at least a location of a first contact between the member 4030 and the pressure sensitive strip 4100 (also referred to herein as the "first contact location") and a location of a second contact between the member 4030 and the pressure sensitive strip 4100 (also referred to herein as the "second contact location"), with the distance between the two contact locations indicating the depth of the hole in the bone.

[0113] The medical device 4500 further comprises a bone probe and a distal tip member. The bone probe and distal tip member may be substantially similar to the bone probe and distal tip member described herein above. Thus, like parts have like reference numbers (i.e., bone probe 208 and distal tip member 1006). In some embodiments, the distal tip member 1006 is a universal tip with a stepped profile to fit various shapes, sizes, and geometries of bone plate openings. The tip member 1106 may be releasably coupled to the distal end of the depth gauge cylinder 4520.

[0114] FIG. 48 is a bottom view of the sensor 4020 depicted in FIG. 47 illustrating the pressure sensing strip 4100. In particular, FIG. 48 shows the pressure sensing strip 4100 extending along the length of the sensor 4020 within the handle body 4530. The sensor 4020 may be shaped to fit into and be retained by a body member of the handle 4510. For example, the body member of the handle 4510 may include tabs, protrusions, or fasteners, such as snap-fit ​​tabs, that secure the sensor 4020 and associated electronics to the first body member 4000.

[0115] 49 is a perspective view of the bottom handle portion of the medical device 4500. The second body member 4010 includes a channel that extends the length of the handle body 4530. The channel 4900 allows the member 4030, which protrudes from the interior surface of the depth gauge cylinder 4520, which is slidably mounted across the handle body 4530, to contact the pressure sensitive strip 4100. This configuration is beneficial because it allows the member 4030 and the pressure sensitive strip 4100 to remain interlocked with one another while also preventing the user's hand or finger from contacting the pressure sensitive strip 4100, which would interfere with its measurement.

[0116] 50 and 51 are cross-sectional views of the medical device 4500 illustrating the depth gauge cylinder 4520 in different positions relative to the handle 4510. In particular, FIG. 50 shows the depth gauge cylinder 4520 in a proximal-most position relative to the handle 4510. In the proximal-most position, the member 4030 contacts a proximal location on the pressure sensing strip 4100. The member 4030 may be in the shape of a wiper arm and include a protrusion or tab that is biased to exert a pressure or force on the pressure sensing strip 4100. FIG. 51 shows a cross-sectional view of the medical device 4500 depicting the depth gauge cylinder 4520 in a distal-most position. In the distal-most position, the member 4030 contacts a distal location on the pressure sensing strip 4100.

[0117] FIG. 52 is an enlarged cross-sectional view of a portion of the depth gauge cylinder 4520 and handle 4510 illustrating one embodiment of a member associated with the depth gauge cylinder 4520 with a pressure sensitive strip 4100 consistent with the present disclosure. In particular, FIG. 52 shows a member 4030 fastened to an interior surface 4080 of the depth gauge cylinder 4520. The member 4030 is shown in the shape of a wiper arm that is biased toward and exerts pressure thereon, according to one embodiment of the present disclosure. FIG. 53 is an enlarged cross-sectional view of a portion of the handle 4510 illustrating another embodiment of a member 4030 associated with the depth gauge cylinder 4520 that engages with the pressure sensitive strip 4100 consistent with the present disclosure. In particular, FIG. 53 shows member 4030, where member 4030 and depth gauge cylinder 4520 are a single piece of material, ie, member 4030 is formed from or is part of and protrudes from depth gauge cylinder 4520.

[0118] 54 and 55 are enlarged cross-sectional views of a portion of a depth gauge cylinder 4520 and a handle 4510 coupled together illustrating an interlocking assembly 5300 for retaining the depth gauge cylinder 4520 and the handle 4510 relative to one another, where the interlocking assembly 5300 transitions between at least a first configuration (FIG. 54) and a second configuration (FIG. 55). The interlocking assembly 5300 includes a depth gauge cylinder 4520 and a portion of a handle body 4530, where the handle body 4530 includes at least first and second sets of protrusions or tabs 5000, 5010, where the depth gauge cylinder 4530 includes corresponding protrusions or tabs 5050 in opposing orientations relative to the first and second sets of tabs 5000, 5010 of the handle body 4530. The first and second sets of tabs 5000, 5010 are each configured to engage with a corresponding tab 5050 on the depth gauge cylinder 4520 and, when engaged, prevent movement of the depth gauge cylinder 4520. In particular, the first set of tabs 5000 are configured to retain the depth gauge cylinder 4520 in a position where the member 4030 of the depth gauge cylinder 4520 is not in contact with the pressure sensitive strip 4100. This configuration is beneficial when shipping the medical device 4500 because keeping the member 4030 out of contact with the pressure sensitive strip 4100 reduces wear and tear and reduces the risk of the member 4030 damaging the sensor when the device is prone to being bumped or dropped during shipping. 55 shows a cross-sectional view of the interlock assembly 5300 in a second configuration, where the second set of tabs 5010 proximal to the first set of tabs 5000 are engaged with corresponding tabs 5050 of the depth gauge cylinder 4520. In this configuration, the interlock assembly 5300 is configured to prevent the depth gauge cylinder 4520 from sliding off the handle 4510 of the medical device 4500 when the depth gauge cylinder is slid distally over the handle body 4530.

[0119] 56 is an exploded view of a medical device 4500 illustrating another embodiment of a member 4030 associated with a depth gauge cylinder 4520 that engages a pressure-sensitive strip 4100 consistent with the present disclosure. The medical device 4500 includes a handle 4510 with a two-piece construction, as discussed above, a first body member 4000 coupled to a second body member 4010. The first body member 4000 defines approximately a first half of the handle 4510 and the second body member 4010 defines a corresponding second half of the handle 4510 relative to a median plane that bisects the medical device 4500 along a longitudinal axis. The first and second body members 4000, 4010 may be coupled together by one of a protrusion, a tab, such as a snap-fit ​​tab or other similar fastener.

[0120] The first and second body members 4000, 4010 may be coupled around the sensor 4020 and partially enclose the sensor 4020 within the handle 4510. The sensor 4020 is configured to determine a position of the depth gauge cylinder 4520 along the length of the handle body 4530 during operation. The position of the depth gauge cylinder 4520 may be determined by the sensor 4020 based at least in part on a location of contact made by a member 4600 protruding through a surface of the depth gauge cylinder 4520. In particular, the member 4600 is configured to be attached to the depth gauge cylinder 4520 via a chamber 5500. The chamber 5500 may protrude through a surface of the depth gauge cylinder 4520 and may be generally perpendicular thereto. The chamber 5500 is configured to facilitate an association between the member 4600 and the pressure sensitive strip 4100 of the sensor 4020 while maintaining a connection between the member 4600 and the depth gauge cylinder 4520. Member 4600 may comprise a ball and spring plunger (shown in FIGS. 56 and 57) or similar mechanical arrangement used to hold a moving part in a temporarily fixed position relative to another moving part.

[0121] FIG. 58 is a side perspective view of a tip member 1006 consistent with the present disclosure. The tip member is a universal tip 1006 that is shaped to fit a variety of bone plates. The profile of the universal tip 1006 comprises a stepped profile including at least two or more distinct and separate stepped portions 5700, each step portion comprising a different diameter. The diameter of the at least two or more stepped portions decreases from the most proximal stepped portion to the most distal stepped portion. In some embodiments, the area between the stepped portions may comprise a sloped portion 5710 for more precise and accurate fit into the bone plate. FIG. 59 is a cross-sectional view of the tip member 1006 taken along line AA of FIG. 58. FIG. 59 depicts the relative diameters of the stepped portions 5700 according to an embodiment of the present disclosure.

[0122] References throughout this specification to "one embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic described in connection with an embodiment is included in at least one embodiment. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0123] The terms and expressions employed herein are used in a descriptive sense, not of limitation, and in the use of such terms and expressions there is no intention to exclude any equivalents of the features (or portions thereof) shown and described, it being recognized that various modifications are possible within the scope of the claims, and therefore the claims are intended to cover all such equivalents.

Claims

[Claim 1] Devices, methods, etc.

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