WO2023211470A1

WO2023211470A1 - Instrument-guiding device for maintaining orientation of a surgical instrument during a medical procedure

Info

Publication number: WO2023211470A1
Application number: PCT/US2022/027089
Authority: WO
Inventors: Roy Anthony Brown; Pete Davis
Original assignee: Marksman Targeting, Inc.
Priority date: 2022-04-29
Filing date: 2022-04-29
Publication date: 2023-11-02

Abstract

An instrument-guiding device is adapted to engage a surgical instrument and provide real-time indication of orientation of the device for purposes of landing the device at a desired target site of a patient's anatomy for purposes of completing a medical procedure. The instrument-guiding device generally makes use of one or more inclinometers and laser light to indicate alignment within a surgical plane and along a surgical trajectory.

Description

INSTRUMENT-GUIDING DEVICE FOR MAINTAINING ORIENTATION OF A SURGICAL INSTRUMENT DURING A MEDICAL PROCEDURE

TECHNICAL FIELD

[0001] The invention relates to medical devices; and more particularly, to medical device configured for orientation of a surgical instrument prior to and/or during a surgical procedure.

BACKGROUND ART

[0002] The Jamshidi needle is a trephine needle used, inter alia, for performing bone marrow biopsy, whereby a cylindrical sample of tissue, a core biopsy specimen, is obtained. It is a cylindrical needle with a tapered cutting tip. The tapered end reduces the potential of crush artifact. In addition, the Jamshidi can be used to identify the lateral aspect of the pedicle, for example, on the ipsilateral side (i.e., the side on which the surgeon is standing) during lateral- medial targeting of the pedicle in connection with a surgical procedure. Jamshidi needles are commonly used in a myriad of surgical procedures, including orthopedic surgeries.

[0003] Conventional techniques utilize a method of human approximation of Jamshidi positioning, from skin entry point toward the target site, confirmed by radiographic image. If the initial human approximation is incorrect or out of alignment with a surgical trajectory according to a radiographic image, the Jamshidi is repositioned and another radiographic image is taken. Learning from the radiographic image(s), a surgeon is capable of eventually positioning the Jamshidi and continuing the procedure. However, this is not without problems. First, there is significant radiation exposure to the patient during the acquisition of many radiographic images. Second, there is tissue disruption with many repositions of the Jamshidi needle. More importantly, however, is the surgical trajectory can be missed altogether, resulting in misplacement of screws or otherwise missing the target site, which can complicate or nullify a surgical procedure.

SUMMARY OF INVENTION

Technical Problem [0004] Conventional techniques for positioning and translating a surgical instrument along a surgical path to engage a target site, such as, without limitation, during a pedicle screw placement or other orthopedic surgery, result in (i) excessive patient exposure to radiation, and (ii) invasive tissue disturbances. Perhaps more importantly, the conventional guess and check type methods are relatively inaccurate, time consuming, and cumbersome, potentially leading to surgeon fatigue and other safety concerns.

Solution to Problem

[0005] An instrument-guiding device is disclosed, the device utilizes laser light projected from a laser emitting device and extending in a linear surgical plane, wherein the intended surgical trajectory lies within the surgical plane, the device comprises features for aligning the device in the surgical plane, and further comprises features for further aligning the device with respect to a gravitational axis while maintained within the surgical plane. Together, the features for aligning the device, namely, features for aligning the laser light about the device and/or instrument coupled to the device, and other features for aligning an angle of the instrument with respect to a gravitational axis, provide a solution to finding the proper surgical trajectory for translating the instrument from a skin entry point to the target site, and for maintaining orientation of the device and instrument coupled therewith during translation toward the target site. While multiple embodiments are disclosed, the solution generally includes providing an instrument-guiding device capable of maintaining the surgical instrument in alignment with the intended surgical path by utilizing laser light projected from a radiographic imaging system and at least one angle inclinometer. Other details are presented in the description of embodiments.

Advantageous Effects of Invention

[0006] Using the proposed instrument-guiding device, in conjunction with a laser emitting device, the laser emitting device configured to visually indicate a surgical plane without undue radiation exposure to the patient, wherein the intended surgical path (ak.a. “surgical trajectory”) extends within the surgical plane and the skin entry point, each of which confirmed by a one or few radiographic images to limit radiation exposure, a surgical procedure can be performed with real-time accuracy of placement, skin entry point, surgical trajectory, and target site end point, such that radiation exposure to the patient is minimized and significantly reduced during the procedure, and the surgical instrument is translated accurately along the surgical path without abusing tissue and reducing time for the procedure.

[0007] Thus, benefits provided with use of the device include, without limitation, less radiation exposure, real-time visual indication of alignment with the surgical trajectory, and mitigation of potential alignment errors, tissue disturbances, and surgeon fatigue.

BRIEF DESCRIPTION OF DRAWINGS

[0008] These and other features and benefits will be appreciated by one with skill in the art upon a thorough review of the appended detailed descriptions and drawings, wherein:

[0009] FIG.l shows a perspective view of an instrument-guiding device for use in guiding a surgical instrument during a surgical procedure, the device being shown in accordance with a first illustrated embodiment, and a counterpart body being hingedly coupled to the primary body;

[0010] FIG.2 shows a front view of the instrument-guiding device in the first illustrated embodiment;

[0011] FIG.3 shows a rear view of the instrument-guiding device in the first illustrated embodiment;

[0012] FIG.4 shows a left-side view of the instrument-guiding device in the first illustrated embodiment;

[0013] FIG.5 shows a right-side view of the instrument-guiding device in the first illustrated embodiment;

[0014] FIG.6 shows a top view of the instrument-guiding device in the first illustrated embodiment;

[0015] FIG.7 shows a bottom view of the instrument-guiding device in the first illustrated embodiment;

[0016] FIG.8 shows a perspective view of an instrument-guiding device for use in guiding a surgical instrument during a surgical procedure, the device being shown in accordance with a second illustrated embodiment, wherein the device includes a primary body with ball-in-tube inclinometer and a laser module receiving well configured to receive a laser emitting device therein;

[0017] FIG.9 shows a spherical bubble inclinometer adapted to nest with the primary body of the instrument-guiding device in any of the illustrated embodiments;

[0018] FIG.10 shows one example of a plurality of possible surgical instruments for use with the instrument-guiding device of any of the illustrated embodiments, here the surgical instrument comprises a shaft and an annular marker integrated with the shaft;

[0019] FIG.11 shows the instrument-guiding device of the second illustrated embodiment being assembled with each of the spherical bubble inclinometer of FIG.9 and the surgical instrument of FIG.10;

[0020] FIG.12 shows the instrument-guiding device and components assembled therewith as shown in FIG.11, and further emitting a linear laser light from the laser emitting device;

[0021] FIG.13 shows a representation of cartesian coordinates and geometric components defining the surgical trajectory;

[0022] FIG.14 shows the representation of FIG.13 taken from zenith (above);

[0023] FIG.15 shows a perspective view of an instrument-guiding device for use in guiding a surgical instrument during a surgical procedure, the device being shown in accordance with a third illustrated embodiment, wherein the device includes a primary body with ball-in-tube inclinometer and a Tuohy-Borst adapter coupled with the primary body for receiving and engaging the surgical instrument;

[0024] FIG.16 shows an exploded view of the instrument-guiding device of FIG.15;

[0025] FIG.17 shows a perspective view of the instrument-guiding device in accordance with a fourth illustrated embodiment;

[0026] FIG.18 shows an alternative perspective view of the instrument-guiding device according to the fourth illustrated embodiment;

[0027] FIG.19 shows a bottom view of the instrument-guiding device according to the fourth illustrated embodiment; [0028] FIG.20 shows a perspective view of the instrument-guiding device in accordance with a fifth illustrated embodiment; and

[0029] FIG.21 show an alternative perspective view of the instrument-guiding device according to the fifth illustrated embodiment.

DESCRIPTION OF EMBODIMENTS

[0030] In the following description, for purposes of explanation and not limitation, details and descriptions are set forth in order to provide a thorough understanding of the embodiments of the invention, namely an instrument-guiding device for guiding a surgical instrument during a surgical procedure. However, it will be apparent to those skilled in the art that the present invention may be practiced in other embodiments, including certain variations or alternative combinations that depart from these details and descriptions.

[0031] Although specific advantages have been enumerated above, various embodiments may include some, none, or all of the enumerated advantages.

[0032] It should be understood at the outset that, although exemplary embodiments are illustrated in the figures and described below, the principles of the present disclosure may be implemented using any number of techniques, whether currently known or not. The present disclosure should in no way be limited to the exemplary implementations and techniques illustrated in the drawings and described below.

[0033] Unless otherwise specifically noted, articles depicted in the drawings are not necessarily drawn to scale.

[0034] Modifications, additions, or omissions may be made to the systems, apparatuses, and methods described herein without departing from the scope of the disclosure. For example, the components of the systems and devices may be integrated or separated. Moreover, the operations of the systems and devices disclosed herein may be performed by more, fewer, or other components and the methods described may include more, fewer, or other steps. Additionally, steps may be performed in any suitable order. As used in this document, “each” refers to each member of a set or each member of a subset of a set.

[0035] For purposes herein, “inclinometer” is an instrument used for measuring angles of slope, elevation, or depression of an object with respect to gravity's direction. A mechanical inclinometer generally includes a ball-in-tube -type inclinometer or a bubble -type inclinometer. A digital inclinometer is differentiated from a mechanical inclinometer and generally comprises an accelerometer or gyroscope.

[0036] The term “elevation angle” is the angle between a horizontal plane and the surgical path or is also equivalent to ninety degrees minus the angle between the surgical path and a gravitational zenith axis. FIG.13 shows a representation of cartesian coordinates and geometric components defining the surgical trajectory. FIG.14 shows the representation of FIG.13 taken from zenith (above).

[0037] The term “radiopaque” means opaque to radiation and therefore visible in x-ray photographs and under fluoroscopy.

[0038] The term “indicia” means markings serving as indicators of measurement, including but not limited to indicators of angle measurement.

[0039] All terms not expressly defined herein are intended to take on their plain and ordinary meaning as would be appreciated by one having skill in the art.

[0040] Now turning to the embodiments, in a general embodiment, a device for guiding a surgical instrument during a surgical procedure is disclosed. The device comprises a primary body extending along a longitudinal axis from a proximal end to a distal end, the primary body comprising a first flange at the proximal end, a second flange at the distal end opposite the first flange, and a curved portion extending between the first flange and the second flange. A channel extends through a longitudinal center of the body in a direction perpendicular to the longitudinal axis. In some embodiments, the device further comprises a first inclinometer coupled to the curved portion of the primary body.

[0041] In some embodiments, the curved portion may be shaped to form a semicircle.

[0042] In some embodiments, the surgical instrument may be one from the group consisting of: a cannula, a radiopaque shaft, a pedicle screw, a Steinman pin, a Moore pin, a Knowles pin, a Denham pin, and a Kirschner wire. The surgical instrument may comprise a radiopaque shaft, wherein the radiopaque shaft comprises an annular radiopaque marker.

[0043] In some embodiments, the device may further comprise a laser module receiving well embodied within the device at the first flange, the second flange, or both, the laser module receiving well configured to receive a laser module therein. The laser module may comprise a linear laser module configured to emit a linear laser light. In some embodiments, the linear laser light and the first inclinometer are in a parallel alignment.

[0044] In some embodiments, the device may further comprise a mid-line indicator extending along each of the first flange and the second flange and configured to indicate alignment of the device within a surgical access plane, wherein, with the mid-line indicator and surgical instrument each configured within the surgical access plane, the first inclinometer is configured to indicate an elevation angle associated with the surgical instrument.

[0045] In some embodiments, the device may further comprise a laser emitting device coupled to the primary body, the laser emitting device having a laser device body and a laser source disposed on the laser device body. In some embodiments, the laser emitting device is fixedly coupled to the primary body. In other embodiments, the laser emitting device is removably coupled to the primary body. The linear laser device may further comprise a gyroscope and a control module, the control module comprising a programmed tolerance relative to a surgical trajectory, wherein upon the device being positioned outside the programmed tolerance relative to the surgical trajectory, the laser source is configured to turn off. In some embodiments, the laser device body may comprise a spherical shape configured to rotate about the channel. The laser emitting device may further comprise a slot extending through a center portion thereof, the slot being concentrically aligned with the channel wherein the slot is configured to receive at least a portion of the surgical instrument inserted therethrough.

[0046] In some embodiments, the device may further comprise a surgical instrument handle disposed on a top portion of the laser emitting device, the surgical instrument handle configured to couple to a surgical instrument. The surgical instrument handle may further comprise a hole extending through a center portion thereof, the hole being concentrically aligned with the channel and the slot wherein the hole is configured to receive a surgical instrument inserted therethrough.

[0047] In some embodiments, the device may further comprise a first aperture extending through the curved portion. The device may include a laser source configured to emit a laser beam through the first aperture. In some embodiments, the device may comprise a second aperture extending through the curved portion. The channel may be disposed between the first and second aperture.

[0048] In some embodiments, the device may further comprise a control module configured to measure impedance of a target site, and further configured to communicate with an audio transducer, wherein the audio transducer is configured to emit a sound based on an impedance of the target site. Said impedance can indicate soft tissue, cancellous bone, cortical bone, metal, or other materials.

[0049] In some embodiments, the device may further comprise a gyroscope, an audio transducer, and a control module comprising a programmed tolerance relative to a surgical trajectory, wherein upon the device being positioned outside the programmed tolerance relative to the surgical trajectory, the audio transducer is configured to emit a sound.

[0050] In some embodiments, the device may further comprise an engagement element having an engagement element channel extending therethrough, wherein the engagement element is configured to concentrically align with the channel and further configured to removably couple to the curved portion.

[0051] In some embodiments, the device may further comprise a second inclinometer. The second inclinometer may orthogonal to the first inclinometer. The device may further comprise a laser emitting device embodied within the primary body, the laser emitting device disposed between the first inclinometer and second inclinometer.

[0052] Now, turning to the drawings, the invention is disclosed in accordance with three illustrated embodiments. However, independent features from one of the three illustrated embodiments may be selectively combined with one or more other features of another of the three illustrated embodiments to form a fourth or subsequent embodiment. These illustrated embodiments are intended only to enable one having skill in the art to practice the invention as claimed.

First Illustrated Embodiment

[0053] FIG.l shows a perspective view of an instrument-guiding device for use in guiding a surgical instrument during a surgical procedure, the device being shown in accordance with a first illustrated embodiment, wherein the device includes a primary body with ball-in-tube inclinometer, and a counterpart body with a bubble inclinometer being hingedly coupled to the primary body.

[0054] As shown in FIG.l, the instrument-guiding device (the “device”) comprises a primary body 10 extending along a longitudinal axis 11 from a proximal end 12 to a distal end 13, the primary body comprising a first flange 14 at the proximal end, a second flange 15 at the distal end opposite the first flange, and a curved portion 16 extending between the first flange and the second flange. The device further comprises a channel 17 extending through a longitudinal center of the primary body in a direction perpendicular to the longitudinal axis; and a first inclinometer 18 coupled to the curved portion of the primary body. Engaged with the channel is an engagement element 19, such as a threaded, longitudinally-slotted, hollow screw adapted to clamp down on a shaft extending therethrough upon tightening. The engagement element may comprise any clamping component known in the art, including but not limited to the aforementioned screw-type clamp, a Touhy -Borst adapter, and the like. Moreover, the first inclinometer may comprise a ball-in-tube -type mechanical inclinometer and indicia extending about the curved portion to indicate an angle with respect to a gravitational zenith axis.

[0055] Similarly, the device further comprises a counterpart body 20 extending along an independent longitudinal axis 21 associated with the counterpart body, the counterpart body comprises a first counterpart flange 24, a second counterpart flange 25 opposite the first counterpart flange, and a curved counterpart portion 26 extending between the first counterpart flange and the second counterpart flange; and a second inclinometer 28 coupled to the curved counterpart portion. The second inclinometer may comprise a bubble-type mechanical inclinometer, and the counterpart body may comprise second indicia for relating the second inclinometer with a desired angular measurement.

[0056] The primary body 10 is shown being hingedly joined to the counterpart body 20 at the first flange 14 and first counterpart flange 24. For example, the counterpart body can be rotatably coupled to the primary body at a pin 29, the pin at least partially extending into each of the first flange and the first counterpart flange forming a hinge therebetween. In this regard, the primary body and first inclinometer 18 can be used to measure a first elevation angle for orienting the surgical instrument with the intended surgical trajectory.

[0057] For example, during preoperative planning or otherwise, a skin entry point can be determined for inserting the surgical instrument into the body of the patient, and a linear surgical trajectory can be determined for translating the surgical instrument from the skin entry point to a target site where a distal tip of the surgical instrument is intended to contact anatomy of the patient. The surgical instrument is ideally inserted at the skin entry point and translated along the surgical trajectory until the distal tip of the surgical instrument contacts the target site at the patient’s anatomy for performing the surgical procedure. Knowing the skin entry point, and the surgical trajectory, the surgical instrument can be accurately advanced during the procedure. However, it is difficult to visualize the surgical trajectory, therefore, a laser light can be emitted from a radiographic image system or thereabout for indicating a surgical plane (a plane within which the surgical trajectory is confined), and the flange of the device may be maintained within the laser light while the distal tip of the surgical instrument is maintained at the skin entry point. In addition, the first inclinometer can be used to orient the surgical instrument and attached device within the surgical plane, or relative thereto, for establishing the surgical trajectory. Thus, with the device and/or surgical instrument aligned with the laser light, the distal tip at the skin entry point, and the first inclinometer at the desired elevation angle, the surgical instrument is oriented along the surgical trajectory and can be translated maintaining such alignment. If the device and/or instrument falls out of alignment with the laser light, it becomes immediately noticeable to the surgeon, who may correct in real time. Similarly, if the first inclinometer reads other than the desired elevation angle, the surgeon may immediately recognize and correct the error. For additional guidance, a securing arm can be affixed to a stationary object (bed, c-arm, or other structural anchor) and provide an adjustable and lockable guide for maintaining orientation of the surgical instrument during the procedure, for example a sleeve within which the surgical instrument can be maintained.

[0058] In some embodiments, the first inclinometer 18 may comprise a ball-in-tube - type inclinometer, and the second inclinometer 28 comprises a bubble-type inclinometer.

[0059] FIGs.2-7 show front, rear, left, right, top, and bottom -views, respectively, of the instrument-guiding device in the first illustrated embodiment.

Second Illustrated Embodiment

[0060] FIG.8 shows a perspective view of an instrument-guiding device for use in guiding a surgical instrument during a surgical procedure, the device being shown in accordance with a second illustrated embodiment, wherein the device includes a primary body with ball-in-tube inclinometer and a laser module receiving well configured to receive a laser module therein.

[0061] With reference to the device shown in FIG.8, it can be appreciated that the device comprises a primary body 10 extending along a longitudinal axis 11 from a proximal end 12 to a distal end 13, the primary body comprising a first flange 14 at the proximal end, a second flange 15 at the distal end opposite the first flange, and a curved portion 16 extending between the first flange and the second flange. The device further comprises a channel 17 extending through a longitudinal center of the primary body in a direction perpendicular to the longitudinal axis; and a first inclinometer 18 coupled to the curved portion of the primary body. The curved portion is shaped to form a semicircle. The channel is configured to receive at least a portion of the surgical instrument inserted therethrough, the first inclinometer may comprise a mechanical inclinometer, such as a ball-in-tube -type inclinometer. Alternatively, the first inclinometer may comprise a digital inclinometer, such as one comprising an accelerometer or gyroscope. The device is configured to aid the alignment of the surgical instrument for deployment thereof during the surgical procedure

[0062] With further reference to FIG.8, the device is shown comprising a laser module receiving well 31 embodied within the device at one of: the first flange and the second flange, the laser module receiving well configured to receive a laser module (not shown) therein. The laser module may comprise any conventional laser module, preferably one that emits linear laser light (a linear laser module), and more preferably one that emits a green linear laser light beam for optimal visualization.

[0063] In an embodiment, with the surgical instrument and the linear laser module each engaged with the device, the linear laser module is configured to orient the linear laser beam in a common plane with the surgical instrument, the common plane can be configured in alignment with the surgical plane as described above.

[0064] Moreover, the device may comprise a mid-line indicator 32 extending along each of the first flange 14 and the second flange 15 and configured to indicate alignment of the device within a surgical access plane (alternatively referred to as the “elevation plane”), wherein, with the mid-line indicator and surgical instrument each configured within the surgical access plane, the first inclinometer 18 is configured to indicate an elevation angle associated with the surgical instrument. For clarity, the device is said to be aligned with the surgical access plane when the linear laser light is aligned with the mid-line indicator. With the distal tip of the surgical instrument contacting the skin entry point, the mid-line indicator aligned with the linear laser beam, and the first inclinometer indicating the desired elevation angle, the instrument and device can be said to be aligned with the surgical trajectory.

[0065] FIG.9 shows a spherical bubble inclinometer 33 adapted to nest with the primary body of the instrument-guiding device in any of the illustrated embodiments. Here, the spherical bubble inclinometer comprises a hollow layer 34 configured to be filled with fluid and a bubble 35 or air-filled floater, wherein the bubble or floater is configured to reflect the highest point of the layer within the sphere. Additionally, indicia can be provided about the hollow layer.

[0066] A base 36 of the spherical bubble inclinometer 33 can be configured as a wrench to tighten or loosen the universal device adapter herein termed the “engagement element” of the surgical instrument itself. The hollow layer of the spherical bubble inclinometer can be provided at thirty-degree latitude. Further, the spherical bubble inclinometer can be configured with an optical path for communicating laser light through a volume of the spherical bubble inclinometer, for example, from a one side of the device (adjacent one flange thereof) to another side of the device (adjacent another flange). Thus, light passing through the spherical bubble inclinometer may be used for aligning trajectories of the device and surgical instrument.

[0067] FIG.10 shows one example of a plurality of possible surgical instruments 37 for use with the instrument-guiding device. Here the surgical instrument comprises a shaft 38, an annular marker 39 integrated with the shaft, and a distal tip 54. Other surgical instruments, namely those with a shaft, can be implemented. Examples include: a pedicle screw, cannula, Steinman pin, Moore pin, Knowles pin, Denham pin, Kirschner wire, and the like.

[0068] FIG.11 shows the instrument-guiding device of the second illustrated embodiment being assembled with each of the spherical bubble inclinometer 33 of FIG.9 and the surgical instrument 37 of FIG.10. The instrument guiding device comprises a primary body 10 having a curved portion 16 with a first flange 14 disposed on a proximal end 12 and a second flange 15 disposed at a distal end 13. A channel 17 extends through a mid-pint of the curved portion and is shown receiving and holding a portion of the surgical instrument. The spherical bubble inclinometer can be rotated to tighten or loosen an engagement element 19 for securing or releasing the surgical instrument from the device. The engagement element comprises an engagement element channel 19a extending through the engagement element, wherein the engagement element is configured to concentrically align with the channel and further configured to removably couple to the curved portion.

[0069] The instrument-guiding device further comprises a laser module receiving well 31 embodied within the device at the first flange 14. Alternative embodiments may have the laser module receiving well embodied on the second flange 15, or both the first flange and the second flange. The laser module receiving well is configured to receive a laser module 41 as shown. In some embodiments, the laser module receiving well is orthogonal to a surface of the first flange, second flange, or both. In such embodiments, the laser module receiving well may comprise a parallel orientation with the surgical instrument 37. In yet other embodiments, the laser module receiving well comprises an angle relative to the surface of the first, flange, second, both wherein angle is less than ninety degrees.

[0070] FIG.12 shows the instrument-guiding device and components assembled therewith as shown in FIG.11, and further emitting a linear laser light 42 from a laser emitting device 40, specifically a laser module 41. The emitted laser beam can indicate a surgical plane common to the surgical instrument and the mid-line indicator of the device. The laser module is disposed within a laser module receiving well 31 that is configured to angle the laser module towards the surgical instrument 37. The instrument-guiding device further comprises a first inclinometer 18 in parallel orientation with the linear laser light. In such a configuration, the linear laser light allows a user of the instrument-guiding device to maintain position in one plane (i.e. left-right with respect to the user), while the first inclinometer allows the instrumentguiding device to maintain position in another plane (i.e. front to back), orthogonal to plane controlled by the linear laser light.

[0071] In some embodiments, the instrument-guiding device may further comprise a secondary laser light forming an angle with the linear laser light 42. The angle may be 90 degrees (orthogonal), 180 degrees, or other angles to indicate an oblique angle. The secondary laser light may comprise a separate laser module, part of the same laser module 41 but a separate laser to the linear laser light, or the secondary laser light may comprise a prism reflection of the linear laser light redirected into a desired angle. In some embodiments, the secondary laser light comprises a different color compared to the linear laser light. The secondary laser light may comprise a linear laser light. After skin has been marked and both angles have been identified, the secondary laser light can aid in keeping the instrument-guiding device aligned during intersection of the surgical instrument. Third Illustrated Embodiment

[0072] FIG.15 shows a perspective view of an instrument-guiding device for use in guiding a surgical instrument during a surgical procedure, the device being shown in accordance with a third illustrated embodiment, wherein the device includes a primary body with ball-in-tube inclinometer and a Tuohy-Borst adapter coupled with the primary body for receiving and engaging the surgical instrument.

[0073] With reference to FIG.15, the device is shown comprising: a primary body 10 extending along a longitudinal axis 11 from a proximal end 12 to a distal end 13, the primary body comprising a first flange 14 at the proximal end, a second flange 15 at the distal end opposite the first flange, and a curved portion 16 extending between the first flange and the second flange. The device further comprises a channel 17 extending through a longitudinal center of the primary body in a direction perpendicular to the longitudinal axis; and a first inclinometer 18 coupled to the curved portion of the primary body. Engaged with the channel is an engagement element 19, such as a Touhy -Borst adapter, though other engagement elements may be similarly implemented. Moreover, the first inclinometer may comprise a ballin-tube -type mechanical inclinometer and indicia extending about the curved portion to indicate an angle with respect to a gravitational zenith axis.

[0074] FIG.16 shows an exploded view of the instrument-guiding device of FIG.15. Here, the primary body 10 is to be assembled with a ball-in-tube inclinometer, and a transparent cover 44 nests on an outer surface of the inclinometer tube 43. Additionally, the Touhy-Borst adapter is provided at an underside of the primary body where it is configured to releasably engage a surgical instrument passing through the channel of the device. Also of note, a midline indicator 32 is provided as cutouts 45 with outwardly facing points 46 instead of a line, wherein the terminal end 47 of the points form a line therebetween for aligning the device with visible laser light. In this regard, one having skill in the art will appreciate a plurality of possible means for indicating a mid-line for aligning a laser light, and such means are intended to be inherently within the instant disclosure.

Fourth Illustrated Embodiment

[0075] FIG.17 shows a perspective view of the instrument-guiding device in accordance with a fourth illustrated embodiment. The instrument-guiding device comprises a primary body 10 extending along a longitudinal axis 11 from a proximal end 12 to a distal end 13, the primary body comprising a first flange 14 at the proximal end, a second flange 15 at the distal end opposite the first flange, and a curved portion 16 extending between the first flange and the second flange. The device further comprises a channel 17 extending through a longitudinal center of the primary body in a direction perpendicular to the longitudinal axis, and a first inclinometer 18 coupled to the curved portion of the primary body.

[0076] The instrument-guiding device further comprises a laser emitting device 40 having a laser device body 50 and a laser source 52 disposed on the laser device body. As shown, the laser device body comprises a spherical shape configured to cradle between the first flange 14 and the second flange 15. Other shapes of the laser device body may also be used. The laser device body comprises a slot extending through a center portion of the laser device body, the slot being concentrically aligned with the channel wherein the slot is configured to receive at least a portion of the surgical instrument 37 inserted therethrough. Disposed at a top of the laser device body is a surgical instrument handle 53 configured to couple with the surgical instrument, thereby securing the laser emitting device to the primary body 10. Disposed at an upper half of the laser emitting device is user inputs 61 which may include features such as on/off actuator, on/off indicator, and/or control settings for any features optionally included within the laser emitting device as can be appreciated by one having skill in the art. The laser source is configured to emit a linear laser light.

[0077] In some embodiments, the surgical instrument handle 53 may further comprise a hole extending through a center portion thereof. The hole is concentrically aligned with both the channel 17 and a slot of the laser emitting device 40 wherein the hole is configured to receive a surgical instrument inserted therethrough. This allows a user of the instrumentguiding device to find a target site and insert a secondary surgical instrument, such as a wire guide, through the hole of the surgical instrument handle, the slot of the later emitting device, the channel, and the surgical instrument 37 towards the target site.

[0078] FIG.18 shows an alternative perspective view of the instrument-guiding device according to the fourth illustrated embodiment. The instrument-guiding device comprises a primary body 10 having a curved portion, a first flange 14, a second flange 15, and a channel 17 extending through the curved portion. Extending through the curved portion is a first aperture 48 and a second aperture 49, whereby the channel is disposed between the first aperture and second aperture. An engagement element 19 is disposed on a bottom portion of the curved portion and is concentrically aligned with the channel. A laser emitting device 40 is disposed over the channel between the first and second flanges. A laser source 52 may be positioned as shown, or alternatively may be positioned into one of the first or second apertures. The laser emitting device is configured to rotate about the channel to allow different positioning of the laser source. The laser source is configured to emit a linear laser light.

[0079] In some embodiments, the instrument-guiding device may further comprise a secondary laser light forming an angle with the laser source 52. The angle may be 90 degrees (orthogonal), 180 degrees, or other angles to indicate an oblique angle. The secondary laser light may comprise a separate laser emitting device, part of the same laser emitting device 40 but a separate laser to the laser source, or the secondary laser light may comprise a prism reflection of the laser source redirected into a desired angle. In some embodiments, the secondary laser light comprises a different color compared to the laser source. The secondary laser light may comprise a linear laser light. After skin has been marked and both angles have been identified, the secondary laser light can aid in keeping the instrument-guiding device aligned during intersection of the surgical instrument.

[0080] FIG.19 shows a bottom view of the instrument-guiding device according to the fourth illustrated embodiment. The instrument-guiding device comprises a primary body 10 having curved portion 16 disposed between a first flange 14 and a second flange 15. The curved portion comprises a first aperture 48 and a second aperture 49 disposed on either side of a channel. The channel is configured to receive and hold a portion of a surgical instrument 37. An engagement element 19 is coupled to both the surgical instrument and curved portion to provide greater stability of the surgical instrument. An optional charging port is shown disposed on a laser emitting device 40 for recharging. In other embodiments, the laser emitting device comprises a single-use battery. The laser emitting device comprises a laser source 52 that is configured to be positioned in a plurality of configurations including through the first aperture or second aperture.

[0081] In some embodiments, the instrument-guiding device may comprise a gyroscope 58 and a control module 60, the control module having a programmed tolerance relative to a surgical trajectory, wherein upon the device being positioned outside the programmed tolerance relative to the surgical trajectory, the laser source 52 is configured to turn off. For example, if the surgical trajectory is determined to be 60 degrees relative to a reference axis, and the programmed tolerance relative to the surgical trajectory is 1 degree, when the instrument-guiding device is positioned outside a range of 59 degrees to 61 degrees, the laser source will turn off and may only turn back on when the position of the instrumentguiding device is positioned within the range of 59 degrees to 61 degrees. In other embodiments, the instrument-guiding device may comprise an audio transducer 55 wherein when the instrument-guiding device is posited outside the range of 59 degrees to 61 degrees, the laser source will remain on and the audio transducer will provide audio feedback that the instrument-guiding device is outside the programmed tolerance relative to the surgical trajectory. The gyroscope, control module, and audio transducer may each be encapsulated within the laser emitting device 40 or may be otherwise coupled to the instrument-guiding device. In some embodiments, the control module may instead or additionally be configured to measure impedance of a target site and further configured to communicate with the audio transducer, wherein the audio transducer is configured to emit a sound based on an impedance of the target site. Impedance of the target site can be measured by an electrical conduit extending through the surgical instrument 37 wherein when a distal tip 54 of the surgical instrument may contact with a target site, the impedance can then be subsequently measured. An example of a means for measuring impedance may include a real time sensing technology named Dynamic Surgical Guidance (DSG) provided by SpineGuard Inc.

Fifth Illustrated Embodiment

[0082] FIG.20 shows a perspective view of the instrument-guiding device in accordance with a fifth illustrated embodiment. The instrument-guiding device comprises a primary body 10 extending along a longitudinal axis 11 from a proximal end 12 to a distal end 13, the primary body comprising a first flange 14 at the proximal end, a second flange 15 at the distal end opposite the first flange, and a curved portion 16 extending between the first flange and the second flange. The device further comprises a channel 17 extending through a longitudinal center of the primary body in a direction perpendicular to the longitudinal axis, and a first inclinometer 18 coupled to the curved portion of the primary body. The primary body further comprises a mid-line indicator 32 having cutouts 45 with outwardly facing points 46 instead of a line, wherein the terminal end 47 of the points form a line therebetween for aligning the device with visible laser light. The cutouts can be utilized to cradle a handle of a surgical instrument wherein the ends of the handle can tightly sit within each cutout.

[0083] The instrument-guiding device further comprises a first inclinometer 18 disposed on a first side 56 of the curved portion 16. A laser emitting device 40 is fixedly coupled to the primary body 10 between the curved portion and the first flange 14. A second inclinometer 28 is disposed between the first flange 14 and the laser emitting device. In such a configuration, the second inclinometer is orthogonal relative to the first inclinometer. The second inclinometer comprises 180 degrees of measurement whereas the first inclinometer comprises less than 180 degrees of measurement, such as 90 degrees as shown. Other degrees of measurement for the first inclinometer can also be utilized. In some embodiments, the instrument-guiding device may comprise an additional inclinometer disposed on a second side 57 opposite the first side.

[0084] FIG.21 show an alternative perspective view of the instrument-guiding device according to the fifth illustrated embodiment. A first inclinometer 18 is disposed on a second side 57 opposite the first side 56. A second inclinometer 28 is coupled to a bottom portion of a first flange 14 wherein a top portion of the first flange remains flat. A laser emitting device 40 having a laser source 52 positioned away from the channel 17.

Other Disclosures

[0085] Now, again with reference to FIGs. 13-14, the instrument-guiding device may be used in conjunction with a laser system during a pedicle screw procedure. In such a procedure, the patient may be positioned prone, wherein the patient’s spine is aligned with the X reference axis indicated in FIG. 13 when visualized from zenith. The target site of the anatomy is noted. However, in the prone position, the pedicle screw is generally not inserted from a purely vertical trajectory, indeed there is a desired surgical trajectory with an azimuth component and an elevation angle component. The intended trajectory in such procedure always extends from the target site (where the screw is placed) through the skin entry point, in a straight line. This information may be gathered during preoperative planning. Thus, using a radiographic imaging system, such as one mounted to a C-arm, the spine can be visualized again from a lateral view, and the target site and anatomy noted. From this view, the angle of the surgical trajectory being one that is ideal for affixing a screw to pedicle, can be determined from lateral, this will be the angle for use with the first inclinometer. The laser is aligned with the target site and the identified angle from lateral, and a marking is optionally drawn on the patient indicating the skin entry point. Now, knowing the skin entry point and angle of ideal surgical trajectory, we simply need to set the radiographic imaging system and laser light emitted therefrom to represent the surgical plane. A rotation to align the laser in the surgical plane is completed, and radiographic image is used to confirm alignment of the anatomy with the laser. From here, the distal tip of the instrument is placed at the skin entry point, the device is aligned with the linear laser light indicating the device and instrument are positioned within the surgical plane, and with the laser light maintained about the mid-line indicator of the device, the first inclinometer is positioned with the intended elevation angle and the instrument is translated into the body of the patient toward the anatomy. While this is one example, there are many indications, procedures, and corresponding methods which generally use the instrumentguiding device as described herein in conjunction with a laser beam to confirm trajectory of a surgical instrument. Nothing in this example shall be construed as limiting of use of the device.

[0086] In any of the illustrated embodiments, or other embodiments as would be appreciated by one having skill in the art, the surgical instrument can be one selected from the group consisting of: a cannula, a radiopaque shaft, a pedicle screw, a Steinman pin, a Moore pin, a Knowles pin, a Denham pin, and a Kirschner wire.

[0087] In one preferred embodiment, the surgical instrument may be one comprising a radiopaque shaft, wherein the radiopaque shaft comprises an annular radiopaque marker coupled or embedded therewith. An annular, or ring-like shape, can comprise a circle, ellipse, diamond, or other annular shape.

[0088] While various details, features, combinations are described in the illustrated embodiments, one having skill in the art will appreciate a myriad of possible alternative combinations and arrangements of the features disclosed herein. As such, the descriptions are intended to be enabling only, and non-limiting. Instead, the spirit and scope of the invention, as intended by the Applicant, is set forth in the appended claims.

INDUSTRIAL APPLICABILITY

[0089] The claimed invention is useful as a device for guiding a surgical instrument during a surgical procedure for enhanced safety and efficacy.

REFERENCE SIGNS LIST

[0090] primary' body (10)

[0091] longitudinal axis (11)

[0092] proximal end (12)

[0093] distal end (13)

[0094] first flange (14)

[0095] second flange (15)

[0096] curved portion (16)

[0097] channel (17)

[0098] first inclinometer (18)

[0099] engagement element (19)

[0100] engagement element channel (19a)

[0101] counterpart body (20)

[0102] independent longitudinal axis (21)

[0103] first counterpart flange (24)

[0104] second counterpart flange (25)

[0105] curved counterpart portion (26)

[0106] second inclinometer (28)

[0107] pin (29)

[0108] laser module receiving well (31)

[0109] mid-line indicator (32)

[0110] spherical bubble inclinometer (33)

[0111] hollow layer (34)

[0112] bubble (35)

[0113] base (36)

[0114] surgical instrument (37)

[0115] shaft (38)

[0116] annular marker (39)

[0117] laser emitting device (40)

[0118] laser module (41)

[0119] linear laser light (42)

[0120] inclinometer tube (43)

[0121] transparent cover (44) [0122] cutouts (45)

[0123] point (46)

[0124] terminal end (47)

[0125] first aperture (48)

[0126] second aperture (49)

[0127] laser device body (50)

[0128] center portion (51)

[0129] laser source (52)

[0130] surgical instrument handle (53)

[0131] distal tip (54)

[0132] audio transducer (55)

[0133] first side (56)

[0134] second side (57)

[0135] gyroscope (58)

[0136] charging port (59)

[0137] control module (60)

[0138] user input (61)

Claims

CLAIMS What is claimed is:

1. A device for guiding a surgical instrument during a surgical procedure, the device comprising: a primary body extending along a longitudinal axis from a proximal end to a distal end, the primary body comprising a first flange at the proximal end, a second flange at the distal end opposite the first flange, and a curved portion extending between the first flange and the second flange; a first inclinometer coupled to the curved portion of the primary body; and a channel extending through a longitudinal center of the body in a direction perpendicular to the longitudinal axis.

2. The device of claim 1, wherein the curved portion is shaped to form a semicircle.

3. The device of claim 1, wherein the surgical instrument is one from the group consisting of: a cannula, a radiopaque shaft, a pedicle screw, a Steinman pin, a Moore pin, a Knowles pin, a Denham pin, and a Kirschner wire.

4. The device of claim 3, said surgical instrument comprising a radiopaque shaft, wherein the radiopaque shaft comprises an annular radiopaque marker.

5. The device of claim 1, further comprising a laser emitting device configured to emit a linear laser light.

6. The device of claim 5, further comprising a laser module receiving well embodied within the device at the first flange, the second flange, or both, the laser module receiving well configured to receive the laser emitting device.

7. The device of claim 5, wherein the linear laser light and the first inclinometer are in a parallel alignment.

8. The device of claim 5, wherein the laser emitting device is coupled to the primary body, the laser emitting device having a laser device body and a laser source disposed on the laser device body.

9. The device of claim 8, wherein the laser emitting device is removably coupled to the primary body.

10. The device of claim 8, further comprising a gyroscope and a control module, the control module comprising a programmed tolerance relative to a surgical trajectory, wherein upon the device being positioned outside the programmed tolerance relative to the surgical trajectory, the laser source is configured to turn off.

11. The device of claim 8, wherein the laser device body comprises a spherical shape configured to rotate about the channel.

12. The device of claim 8, the laser emitting device further comprising a slot extending through a center portion thereof, the slot being concentrically aligned with the channel wherein the slot is configured to receive at least a portion of the surgical instrument inserted therethrough.

13. The device of claim 12, further comprising a surgical instrument handle disposed on a top portion of the laser emitting device, the surgical instrument handle configured to couple to a surgical instrument.

14. The device of claim 13, the surgical instrument handle further comprising a hole extending through a center portion thereof, the hole being concentrically aligned with the channel and the slot wherein the hole is configured to receive a surgical instrument inserted therethrough.

15. The device of claim 8, further comprising a first aperture extending through the curved portion, wherein the laser source is configured to emit the linear laser light through the first aperture.

16. The device of claim 15, further comprising a second aperture extending through the curved portion.

17. The device of claim 16, wherein the channel is disposed between the first aperture and the second aperture.

18. The device of claim 5, further comprising a secondary laser light.

19. The device of claim 18, wherein the secondary laser light and the linear laser light are in an orthogonal relationship.

20. The device of claim 18, wherein the linear laser light and the secondary laser light comprise different colors.

21. The device of claim 1, further comprising a mid-line indicator extending along each of the first flange and the second flange and configured to indicate alignment of the device within a surgical access plane, wherein, with the mid-line indicator and surgical instrument each configured within the surgical access plane, the first inclinometer is configured to indicate an elevation angle associated with the surgical instrument.

22. The device of claim 1, further comprising a control module configured to measure impedance of a target site, and further configured to communicate with an audio transducer, wherein the audio transducer is configured to emit a sound based on an impedance of the target site.

23. The device of claim 1, further comprising: a gyroscope; an audio transducer; and a control module comprising a programmed tolerance relative to a surgical trajectory; wherein upon the device being positioned outside the programmed tolerance relative to the surgical trajectory, the audio transducer is configured to emit a sound.

24. The device of claim 1, further comprising an engagement element having an engagement element channel extending therethrough, wherein the engagement element is configured to concentrically align with the channel and further configured to removably couple to the curved portion.

25. The device of claim 1, further comprising a second inclinometer.

26. The device of claim 24, wherein the second inclinometer is orthogonal to the first inclinometer.

27. The device of claim 25, further comprising a laser emitting device embodied within the primary body, the laser emitting device disposed between the first inclinometer and second inclinometer.