Patent Application
20220409289
The present disclosure relates generally to ultrasound imaging, and more specifically to a system and method for using ultrasound imaging to safely place one or more instruments through tissue without damaging nearby neurovascular structures.
Ultrasound imaging or sonography is a diagnostic medical procedure that uses high-frequency sound waves to produce visual images of anatomical features inside the body, including but not limited to organs, tissue, and blood flow. As a result, ultrasound imaging can be a useful tool for providing a real-time visualization of internal anatomy prior to accessing a surgical target site. However, traditional ultrasound techniques are not effective at detecting certain kinds of tissue including neural tissue, and thus traditional ultrasound techniques may be unreliable for visualization of internal anatomy for certain procedures, for example such as a lateral trans-psoas approach to the spine.
The present disclosure describes an intraoperative ultrasound probe system and method capable of using ultrasound imaging to safely guide the placement of one or more instruments (e.g., needle, guide wire, dilator, cannula, etc.) through tissue (e.g., muscle, fat, brain, liver, lung, etc.) without damaging nearby neurovascular structures. According to one embodiment, and by way of example only, the intraoperative ultrasound probe system includes an ultrasonic transducer probe configured for emitting and receiving ultrasound waves and a computer system including a processor for processing the data received by the probe and a display unit configured to display an ultrasound image based on the processed data. The ultrasonic transducer probe is configured for insertion into an operative corridor in a surgical patient so that the distal end of the ultrasonic transducer probe may be brought into close proximity or contact with target anatomy. For example, in a lateral access spine surgery the distal end of the ultrasonic transducer probe may be placed in close proximity to the psoas muscle. Ultrasound imaging may then be used to locate and identify certain anatomical structures to help the surgeon visually determine a safe trajectory for a guide wire through the psoas muscle to a target spinal disc space. Once the probe is in position proximate the psoas muscle (including but not limited to direct contact), ultrasound imaging may be performed in which the computer receives radio frequency (RF) data from the probe and causes a B-mode image of the visible anatomical structures (e.g. muscle, bone, etc.) to be displayed on the display unit.
In some embodiments, the intraoperative ultrasound probe system includes a probe configured for emitting and receiving ultrasound waves in electronic communication with an electronic device (e.g. computer) including a computer processor for processing data received by the probe, software for providing a set of executable instructions to the processor, and a display unit (integrated or standalone) configured to display an ultrasound image based on the processed data. The electronic device may be any stationary or portable computer system including a processor, software, and the ability to communicate with a display unit (integrated or standalone), including but not limited to a laptop, desktop, workstation, personal digital assistant, server, blade server, mainframe, cellular telephone, smartphone, tablet computer, cloud-based computing devices, and/or other similar computing devices. In some embodiments, the intraoperative ultrasound probe system may include include a variety of instruments and accessories, including but not limited to a transducer stabilizer, an stabilizer tube, dilator guide, dilator, and a K-wire.
In some embodiments, the ultrasonic transducer probe comprises an elongated housing member having an elongated main body portion, a distal end, a proximal end, a superior face, an inferior face, an inner cavity, and a proximal aperture through which a communication cable passes that may connect the probe to one or more of a power source, display device, computer, and the like. In some embodiments, the main body portion includes an elongated coupling track positioned on the superior face that extends substantially the length of the main body portion and may be configured to slidably couple with one or more attachments or accessories. In some embodiments, the main body portion comprises a passive locking element configured to engage one or more accessories, including but not limited to a transducer stabilizer. In some embodiments, the passive locking element comprises a recess formed within the superior face near the proximal end of the coupling track. Formation of the recess may create a pair of sidewalls positioned on either side of the recess and extending partially the length of the recess, leaving a gap between the distal ends of the sidewalls and the distal end of the recess. In some embodiments, the distal end has an enlarged width to accommodate the ultrasonic transducer array disposed within the interior cavity at the distal end of the probe. In some embodiments, the distal end further comprises a generally planar leading face having smooth rounded edges to minimize trauma to surrounding tissue as the probe is advanced and retracted through the operative corridor. In some embodiments, the proximal end includes curved portion such that the proximal end is laterally offset from the main body portion in the inferior direction.
In some embodiments, the intraoperative ultrasound probe system of the present disclosure further comprises a transducer stabilizer. In some embodiments, the distal region of the probe is sized and configured to slidingly engage the stabilizer tube. However, the proximal region, being of narrower width than the distal region (in some embodiments), does not itself engage the stabilizer tube and as a result would be free to move (and thereby change trajectory angle during use) absent a stabilizing intermediate structure. Thus the transducer stabilizer is configured to attach to the transducer probe near the proximal region and further engage the stabilizer tube such that the narrower proximal region of the probe is secured in position when the probe is inserted into the stabilizer tube.
In some embodiments, the transducer stabilizer has a main body portion comprising a superior surface, inferior surface, and a central recess formed therein that is open to one side of the stabilizer. In some embodiments, the superior surface is generally planar with smooth rounded edges such that the stabilizer has a generally rounded rectangle cross-sectional shape. In some embodiments, the central recess is sized and configured to receive a portion of the proximal region of the probe therein. In some embodiments, the stabilizer further includes a first engagement element positioned at the closed side of the recess (opposite the open side) and configured to engage the probe to couple the stabilizer to the probe, for example by engaging the passive locking element (or similar feature) on the probe. In some embodiments, the stabilizer further includes a visual indicator that will indicate a positive locking engagement between the stabilizer and probe.
In some embodiments, the transducer stabilizer may be further configured to securely engage the stabilizer tube while simultaneously coupled to the probe. To facilitate this engagement, the stabilizer may include a pair of inferior buttresses extending from the inferior surface of the main body portion. The inferior buttresses may be located at either end of the stabilizer (e.g. one on each side of the central recess) and may have a curved perimeter shape that corresponds to the perimeter shape of the interior lumen of the stabilizer tube such that the inferior buttresses are sized and shaped to be snugly received within the interior lumen of the stabilizer tube. The main body portion (including the superior and inferior surfaces) may have a slightly larger perimeter than the buttresses so as to create an overhang or lip that prevents the entire stabilizer from entering the interior lumen of the stabilizer tube. A pair of elongated flanges may extend further inferiorly into the interior lumen (when coupled to the stabilizer tube) to provide further stability. As a result, in some embodiments the transducer stabilizer may be configured to “sit” on top of the stabilizer tube when engaged thereto and maintain the proximal end of the probe in a fixed orientation relative to the stabilizer tube.
In some embodiments, the transducer stabilizer may be manufactured from a medical-grade radiolucent material such as PEEK (poly-ether-ether-ketone), PEKK (poly-ether-ketone-ketone), etc. and may further contain radiographic markers positioned to signal the location of one or more of the guide channels of the dilator guide under fluoroscopy. In some embodiments, the radiographic markers may be spot markers to indicate the location of the top openings of the guide channels of the dilator guide and/or a linear marker to indicate the alignment and/or angular orientation of the guide channels. In some embodiments, the transducer stabilizer may be made from anodized aluminum.
In some embodiments, the intraoperative ultrasound probe system of the present disclosure further comprises a stabilizer tube. In some embodiments, the stabilizer tube comprises an elongated cannulated sleeve having a proximal end, a distal end, and an interior lumen extending from the proximal end to the distal end. In some embodiments, the sleeve and the interior lumen each have a generally rounded rectangle cross-sectional shape. In some embodiments, the interior lumen may be sized and configured to receive at least a portion of the stabilizer buttresses therein at the proximal end and to further receive the dilator guide therein. In some embodiments, the sleeve further comprises a proximal aperture and a distal aperture at the respective ends of the interior lumen to enable ingress and egress of various surgical instruments through the stabilizer tube. In some embodiments, the proximal end may further include a superior flange to buttress the laterally-offset curved portion of the probe and a laterally extending flange configured to engage with an articulating arm (for example) to register the stabilizer tube (and by extension any instruments associated with it such as the probe, dilator guide, etc.) to a bedrail in a fixed orientation.
In some embodiments, the intraoperative ultrasound probe system of the present disclosure further comprises a dilator guide. In some embodiments, the dilator guide comprises an elongated cannulated sleeve having a proximal end, a distal end, and one or more guide channels in the form of interior lumens extending from the proximal end to the distal end and having proximal openings and distal openings to allow ingress and egress of various instrumentation therethrough. In some embodiments, the dilator guide may have a plurality of guide channels extending therethrough. In some embodiments, the dilator guide may have three cylindrical guide channels, including a central guide channel and a pair of lateral guide channels. In some embodiments, the guide channels may be sized and configured to receive at least one dilator therethough, however any instrument having a diameter or width smaller than the diameter of the guide channels may pass through. In some embodiments, the proximal end of the dilator guide is configured to “sit” on top of the stabilizer tube when engaged thereto and maintain the dilator guide (and importantly, the guide channels in a fixed orientation relative to the stabilizer tube. In some embodiments, the distal end of the dilator guide has a perimeter surface having a size and shape corresponding to the perimeter size and shape of the interior lumen (when coupled with the stabilizer tube) so that the distal end is snugly received within the interior lumen to provide further stability.
In some embodiments, the ultrasonic transducer probe may be cannulated to enable advancement of a surgical instrument (e.g. dilator, K-wire) through the probe. In some embodiments, the cannulation comprises an interior corridor extending substantially the length of the main body portion and configured to allow passage of one or more surgical instruments (e.g. surgical guide wire) therethrough.
In some embodiments, the surgical guide wire may include a series of echogenic elements configured to reflect sound waves to make the surgical guide wire “visible” during ultrasound imaging. In some embodiments, the echogenic elements comprise one or more of notches, ridges, and the like.
In some embodiments, the probe comprises an elongated housing member having a generally hourglass shape. In some embodiments, the elongated housing member may include an enlarged-width distal end comprising an outer surface having a curved perimeter shape that corresponds to the perimeter shape of the interior lumen of the stabilizer tube, encouraging a snug interaction between the distal end and the stabilizer tube to minimize or eliminate non-translational movement of the distal end relative to the stabilizer tube during use. In some embodiments, the elongated housing member may include an enlarged-width proximal end comprising an outer surface having a curved perimeter shape that corresponds to the perimeter shape of the interior lumen of the stabilizer tube, encouraging a snug interaction between the proximal end and the stabilizer tube to minimize or eliminate non-translational movement of the proximal end relative to the stabilizer tube during use.
In some embodiments, the probe further comprises a proximal extension comprising an inner cavity through which a communication cable passes that may connect the probe (e.g. including but not limited to the transducer array) to one or more of a power source, display device, computer, and the like. In some embodiments, the proximal extension may be curved or angled such that the proximal end is laterally offset from the distal end, creating additional space to maneuver instrumentation as the probe is advanced or retrieved from the operative corridor, for example via the stabilizer tube.
In some embodiments, the electronic device comprises a moveable unit having a computer housing (e.g. comprising a processor, software, data storage module, and a communications module configured for wired and/or wireless communication with the probe), a base unit, and a display unit coupled to a vertical displacement element. In some embodiments, the base unit has a plurality of wheel elements (e.g. castors, etc.) that enable a user to move the moveable unit to any desired position in a room. In some embodiments, the electronic device including the computer housing and display unit may be connected to a power source, either integrated with the electronic device or connected to A/C power via a power cord. In some embodiments, the electronic device maybe A/C capable with a battery backup. In some embodiments, the data storage module may include internal storage or external storage. In some embodiments, the display unit may have a screen comprising a touch-screen interface that enables the user to provide instructions to the computer by selecting buttons or icons that the computer presents on the screen.
In some embodiments, direct visualization of the dilator/K-wire placement may be utilized prior to removal of the stabilizer tube.
In some embodiments, the system may include integration of three-dimensional soft tissue mapping capabilities enabled by image-guided navigation. In some embodiments, robotic automation may be employed to enhance precision and efficiency.
As additional description to the embodiments described below, the present disclosure describes the following embodiments.
Embodiment 1 is an intraoperative ultrasound probe system for guiding access through intervening anatomical structure to a surgical target site, comprising: an ultrasound probe having a proximal end, a distal end, an electronic communication element, and a transducer array positioned near the distal end, the transducer array including at least one emitting element configured to emit high-frequency sound waves within a proximity of the distal end and in a direction away from the distal end, the transducer array further comprising at least one sensing element configured to receive reflected sound waves; an electronic device in electronic communication with the ultrasound probe by way of the electronic communication element, the electronic device having at least one computer processor and a data storage unit; a display unit in electronic communication with the electronic device; and computer-readable media including instructions that, when executed by one or more processors, are configured to cause the computer processor to: direct the ultrasound probe to emit high frequency sound waves from the at least one emitting element at least one of in the direction of and through the intervening anatomical structure; convert reflected sound waves received by the at least one sensing element to radio frequency data; generate a B-mode image of the intervening anatomical structure within the proximity of the distal end from the radio frequency data; generate a secondary image of neurovascular anatomy in the proximity of the distal end; and provide, on the display unit, a real-time presentation of: (i) the generated B-mode image of the intervening anatomical structure; (ii) the secondary image of the neurovascular anatomy superimposed on the B-mode image; and (iii) a highlighted position of at least one of a nerve, muscle, and bone superimposed on the secondary image and the B-mode image.
Embodiment 2 is the system of embodiment 1, wherein the electronic element comprises at least one of a communication cable and a wireless transmission platform.
Embodiment 3 is the system of embodiments 1 or 2, further including an elongated access conduit comprising a proximal end, a distal end, and an interior lumen extending between the proximal and distal ends, the interior lumen configured to receive the probe therethrough.
Embodiment 4 is the system of any of embodiments 1 through 3, wherein the access conduit further comprises a laterally extending flange at the proximal end, the laterally extending flange configured to interact with an articulating arm to register the access conduit in a fixed orientation.
Embodiment 5 is the system of any of embodiments 1 through 4, wherein the ultrasound probe includes one or more radiographic markers to indicate at least one of the location and orientation of potential access pathways through the intervening anatomical structure under fluoroscopy.
Embodiment 6 is the system of any of embodiments 1 through 5, wherein the computer-readable media includes further instructions that, when executed by one or more processors, are configured to cause the computer processor to provide, on the display unit, a real-time presentation of: (iii) one or more potential access pathways through the intervening anatomical structure based on the location and orientation of the radiographic markers, superimposed on the B-mode image.
Embodiment 7 is the system of any of embodiments 1 through 6, further comprising an elongated dilator guide configured to nest within the interior lumen of the access conduit, the elongated dilator guide having at least one guide channel extending therethrough, the at least one guide channel configured to receive a dilator therein.
Embodiment 8 is the system of any of embodiments 1 through 7, wherein the dilator has a shaped end configured for advancement through the intervening anatomical structure and an inner lumen configured to allow passage of a guide wire therethrough.
Embodiment 9 is the system of any of embodiments 1 through 8, wherein the elongated dilator guide comprises three guide channels extending in parallel therethrough.
Embodiment 10 is a method of guiding access through an intervening anatomical structure to a surgical target site of a patient positioned on an operating surface, comprising: (1) providing an ultrasound probe assembly, the probe assembly comprising an ultrasound probe disposed within an interior lumen of an access conduit; (2) advancing a distal end of the ultrasound probe assembly through an incision in the patient's skin to a superficial aspect of an anatomical structure that is between the patient's dura and the surgical target site, the probe having a proximal end, a distal end, an electronic communication element, and a transducer array positioned near the distal end, the transducer array including at least one emitting element configured to emit high-frequency sound waves within a proximity of the distal end and in a direction away from the distal end, the transducer array further comprising at least one sensing element configured to receive reflected sound waves and convert the reflected sound waves to radio frequency data; (3) performing ultrasound imaging to generate a B-mode image of the intervening anatomical structure from the radio frequency data obtained by the probe; (4) displaying the B-mode image of the intervening anatomical structure on a display device; (5) displaying a secondary image of neurovascular anatomy in the proximity of the distal end superimposed on the B-mode image; (6) displaying a highlighted position of at least one of a nerve, muscle, and bone superimposed on the secondary image and the B-mode image; and (7) selecting an access pathway through the intervening anatomical structure based on the displayed B-mode image and superimposed secondary image.
Embodiment 11 is the method of embodiment 10, further comprising the step of: registering the access conduit in a fixed orientation relative to the operating surface.
Embodiment 12 is the method of embodiments 10 or 11, wherein the probe includes one or more radiographic markers to indicate at least one of the location and orientation of potential access pathways under fluoroscopy.
Embodiment 13 is the method of any of embodiments 10 through 12, further comprising the step of: displaying a real-time presentation of one or more potential access pathways through the intervening anatomical structure based on the location and orientation of the radiographic markers, superimposed on the B-mode image.
Embodiment 14 is the method of any of embodiments 10 through 13, further comprising the steps of: removing the probe from the access conduit; and advancing an elongated dilator guide into the interior lumen of the access conduit, the dilator guide configured to nest within the interior lumen of the access conduit, the elongated dilator guide having at least one guide channel extending therethrough, the at least one guide channel corresponding to the selected access pathway and configured to receive a dilator therein.
Embodiment 15 is the method of any of embodiments 10 through 14, further comprising the step of: advancing an elongated dilator through the guide channel corresponding to the selected access pathway, and further through the intervening anatomical structure along the selected access pathway, the dilator having a shaped end configured to facilitate advancement through the intervening anatomical structure and an inner lumen configured to allow passage of a guide wire therethrough.
Embodiment 16 is the method of any of embodiments 10 through 15, further comprising the step of: advancing a guide wire through the dilator until a distal end of the guide wire is registered to the surgical target site.
Embodiment 17 is the method of any of embodiments 10 through 17, further comprising the steps of: removing access conduit from the incision; and removing the dilator from the incision.
Many advantages of the present disclosure will be apparent to those skilled in the art with a reading of this specification in conjunction with the attached drawings, wherein like reference numerals are applied to like elements and wherein:
Illustrative embodiments of the invention are described below. In the interest of clarity, not all features of an actual implementation are described in this specification. It will of course be appreciated that in the development of any such actual embodiment, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which will vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure. The intraoperative ultrasound probe system and related methods disclosed herein boasts a variety of inventive features and components that warrant patent protection, both individually and in combination.
The present disclosure describes an intraoperative ultrasound probe system and related methods capable of using ultrasound imaging to help a surgeon visually determine a trajectory to safely place one or more instruments (e.g., needle, guide wire, dilator, cannula, etc.) through tissue (e.g., muscle, fat, brain, liver, lung, etc.) without damaging nearby neurovascular structures.
The main body portion 32 further comprises a passive locking element 54 configured to engage one or more accessories, including but not limited to (and by way of example only) a cantilever locking element of a guide sleeve (not shown), and/or a portion of the transducer stabilizer 22 described below. By way of example only, the passive locking element 54 comprises a recess 56 formed within the superior face 38 near the proximal end of the coupling track 48. Formation of the recess 56 creates a pair of sidewalls 58 positioned on either side of the recess 56 and extending partially the length of the recess 56, leaving a gap 60 between the distal ends of the sidewalls 58 and the distal end of the recess 56.
The distal end 34 has an enlarged width (for example) to accommodate the ultrasonic transducer array 62 disposed within the interior cavity 42 at the distal end 34 of the probe 12. By way of example only, the transducer array 62 comprises at least one emission element 63 and at least one sensing element 65. The at least one emission element 63 may be configured to emit high-frequency sound pulses in a direction away from the distal end 34. At least some of the emitted high-frequency sound pulses may be reflected by boundaries between body tissues. The at least one sensing element 65 may be configured to receive the reflected sound pulses as radio frequency (RF) data, which is then transmitted to the processor 16 by way of the communication cable 46 (for example) or other suitable method of electronic communication (e.g. wired, wireless, WiFi, Bluetooth, etc.). The distal end 34 further comprises a leading face 64. By way of example, the leading face 64 may be generally planar with smooth rounded edges to minimize trauma to surrounding tissue as the probe 12 is advanced and retracted through the operative corridor.
The proximal end 36 includes curved portion 66 such that the proximal end 36 is laterally offset from the main body portion 32 in the inferior direction. By way of example, the superior and inferior faces 38, 40, respectively, are generally planar with smooth, rounded edges to minimize trauma to surrounding tissue as the probe 12 is advanced through the operative corridor.
By way of example only, the transducer stabilizer 22 has a main body portion 68 comprising a superior surface 70, inferior surface 72, a central recess 74 formed therein that is open to one side of the stabilizer 22, and a lateral channel 75 extending through the main body portion. The superior surface 70 is generally planar with smooth rounded edges such that the stabilizer 22 has a generally rounded rectangle cross-sectional shape (see e.g.
The transducer stabilizer 22 is further configured to securely engage the stabilizer tube 24 while simultaneously coupled to the probe 12. To facilitate this engagement, the stabilizer 22 further includes a pair of inferior buttresses 80 extending from the inferior surface 72 of the main body portion 68. The inferior buttresses 80 are located at either end of the stabilizer (e.g. one on each side of the central recess 74) and have a curved perimeter shape that corresponds to the perimeter shape of the interior lumen 96 of the stabilizer tube 24 such that the inferior buttresses 80 are sized and shaped to be snugly received within the interior lumen 80 of the stabilizer tube 24. The main body portion 68 (including the superior and inferior surfaces 70, 74) have a slightly larger perimeter than the buttresses 80 so as to create an overhang or lip 82 that prevents the entire stabilizer 22 from entering the interior lumen 96 of the stabilizer tube 24. A pair of elongated flanges 84 extend further inferiorly into the interior lumen 96 (when coupled to the stabilizer tube 24) to provide further stability. As a result, the transducer stabilizer 22 is configured to “sit” on top of the stabilizer tube 24 when engaged thereto and maintain the proximal end 46 of the probe 12 in a fixed orientation relative to the stabilizer tube 24.
The transducer stabilizer 22 may be manufactured from a medical-grade radiolucent material such as PEEK (poly-ether-ether-ketone), PEKK (poly-ether-ketone-ketone), etc. and may further contain radiographic markers 86, 88 positioned to signal the location of one or more of the guide channels 116 of the dilator guide 26 (described below), and by extension the location of possible access pathways, under fluoroscopy. By way of example, radiographic markers 86 may be spot markers to indicate the location of the top openings of the guide channels 116 of the dilator guide 26. The radiographic marker 88 may be a linear marker to indicate the alignment and/or angular orientation of the guide channels 116. In some embodiments, the transducer stabilizer may be made from anodized aluminum. In some embodiments, the probe 10 may include internal metallic structure that function as radiographic elements to indicate where the multiple guide channels 116 of the dilator guide 26 will be located once the dilator guide 26 is advanced into the stabilizer tube 24, enabling the surgeon to ensure that all of the potential guide channels 116 are also in alignment with the surgical target site 426.
The proximal end 112 includes a superior surface 122, an inferior surface 124, and a plurality of sidewalls 126 extending between the superior and inferior surfaces 122, 124. The superior surface is generally planar, has a rounded rectangle perimeter shape, and includes a plurality of apertures 118 (e.g. proximal guide channel apertures 118, 118′, 118″) formed therein. The inferior surface 124 includes an inferior buttress 128 extending inferiorly therefrom, the inferior buttress 128 having a perimeter sized and shaped to correspond to the perimeter shape of the interior lumen 96 of the stabilizer tube 24, such that the inferior buttress 128 is snugly received within the interior lumen 96 of the stabilizer tube 24. The inferior surface 124 has a slightly larger perimeter than the buttress 128 so as to create an overhang or lip 130 that prevents the proximal end 112 of the dilator guide 26 from entering the interior lumen 96 of the stabilizer tube 24. As a result, the proximal end 112 is configured to “sit” on top of the stabilizer tube 24 when engaged thereto and maintain the dilator guide 26 (and importantly, the guide channels 116 in a fixed orientation relative to the stabilizer tube 24. Similarly, the distal end 114 of the dilator guide 26 has a perimeter surface 132 having a size and shape corresponding to the perimeter size and shape of the interior lumen 96 (when coupled with the stabilizer tube 24) so that the distal end 114 is snugly received within the interior lumen 96 to provide further stability.
The sidewalls 126 form the outer perimeter of the proximal end 112 and include a plurality of friction elements 134 (e.g. ridges, knobs, surface roughening, and the like) dispersed thereupon. The friction elements 134 enable a user to grab hold of and exert pulling force on the dilator guide 26 to remove the dilator guide 26 from the stabilizer tube 24 after use.
The distal end 144 has an enlarged width (for example) to accommodate the ultrasonic transducer array 172 disposed within the distal end 144. By way of example only, the transducer array 172 comprises at least one emission element and a least one sensing element. The at least one emission element may be configured to emit high-frequency sound pulses in a direction away from the distal end 144. At least some of the emitted high-frequency sound pulses may be reflected by boundaries between body tissues. The at least one sensing element may be configured to receive the reflected sound pulses as radio frequency (RF) data, which is then transmitted to the processor 16 by way of the communication cable 156 (for example) or other suitable method of electronic communication (e.g. wired, wireless, WiFi, Bluetooth, etc.). The distal end 144 further comprises a leading face 174. By way of example, the leading face 174 may be generally planar with smooth rounded edges to minimize trauma to surrounding tissue as the probe 140 is advanced and retracted through the operative corridor. The proximal end 146 may include a curved portion 176 such that the proximal end 146 is laterally offset from the main body portion 142 in the inferior direction. By way of example, the superior and inferior faces 148, 150, respectively, are generally planar with smooth, rounded edges to minimize trauma to surrounding tissue as the probe 140 is advanced through the operative corridor.
By way of example, the probe 140 may be cannulated such that the probe 140 comprises an interior corridor 178 extending substantially the length of the main body portion 142 and configured to allow passage of one or more surgical instruments (e.g. dilator 28, K-wire 30) therethrough. The distal end 144 of the probe 140 includes a distal aperture 180 formed within the leading face 174, the distal aperture 180 comprising the distal terminus of the interior corridor 178 and allowing ingress into and/or egress from the interior corridor 178. The proximal terminus of the interior corridor 178 comprises a proximal aperture 182 positioned distally of the curved portion 176. The proximal aperture 182 comprises the proximal terminus of the interior corridor 178 and allows ingress into and/or egress from the interior corridor 178. The K-wire 30 may include a series of echogenic elements 184 (e.g. notches, ridges, etc.) configured to reflect sound waves to make the K-wire 30 “visible” during ultrasound imaging.
By way of example only, the interior corridor 178 may occupy space within the inner cavity 152 of the probe 140, but is physically separate from the inner cavity 152 to ensure that no foreign material (e.g. patient tissue, etc.) may penetrate the inner cavity 152. Thus, internal probe elements (e.g. transducer array 172, communication cable 156, etc.) may be positioned within the inner cavity 152 around the interior corridor 178. Providing the probe 140 with a cannulation (e.g. interior corridor 178) enables an instrument (e.g. dilator 28, K-wire 30) to be advanced directly through the probe 140 without the need for a separate insertion corridor (e.g. dilator guide 26), which may be advantageous in some surgical situations in that the instrument is inserted directly through the field of view as opposed to alongside the field of view.
The distal end 194 has an enlarged width (for example) to accommodate an ultrasonic transducer array 204 (e.g. including at least one emission element and at least one sensing element) disposed within the interior cavity 202 at the distal end 194 of the probe 190. The distal end 194 further comprises a leading face 206. By way of example, the leading face 206 may be generally planar with smooth rounded edges to minimize trauma to surrounding tissue as the probe 190 is advanced and retracted through the operative corridor. By way of example only, the distal end 194 of the elongated housing member 192 comprises an outer surface 207 having a curved perimeter shape that corresponds to the perimeter shape of the interior lumen 248 of the stabilizer tube 240 (and/or interior lumen 96 of stabilizer tube 24). This shape encourages a snug interaction between the distal end 194 and the stabilizer tube 240 to minimize or eliminate non-translational movement of the distal end 194 relative to the stabilizer tube 240 during use. By way of example only, the proximal end 196 of the elongated housing member 192 may also have an enlarged width, giving the elongated housing member 192 a generally hourglass shape.
The probe 190 further comprises a proximal extension 208 extending proximally from the proximal end 196 of the elongated housing member 192. The proximal extension 208 comprises an elongated body 210 having a distal end 212, a proximal end 214, and an inner cavity 216 extending therethrough from the distal end 212 to the proximal end 214. The distal portion of the inner cavity 216 is continuous with the inner cavity 202 of the elongated housing member 192. The proximal end 214 further comprises a proximal aperture 218 through which a communication cable 220 passes that may, by way of example only, connect the probe 190 (e.g. including but not limited to the transducer array 204) to one or more of a power source (not shown), display device 20, computer 14, etc.
By way of example, the proximal extension 208 includes a curved portion 222 configured such that the proximal end 214 is laterally offset from the distal end 212 and thus the elongated housing member 192 in the inferior direction.
By way of example, the probe 190 is configured to securely engage the stabilizer tube 240 and/or stabilizer tube 24 without the need for additional accessories. As previously mentioned, the proximal end 196 of the elongated housing member 192 may have an enlarged width, giving the elongated housing member 192 a generally hourglass shape. More specifically, the proximal end 196 of the elongated housing member 192 comprises an outer surface 224 having a curved perimeter shape that corresponds to the perimeter shape of the interior lumen 248 of the stabilizer tube 240 such that the proximal end 196 is sized and shaped to be snugly received within the interior lumen 248 of the stabilizer tube 240. This shape encourages a snug interaction between the proximal end 196 and the stabilizer tube 240 to minimize or eliminate non-translational movement of the proximal end 196 relative to the stabilizer tube 240 during use of the probe 190. The distal end 212 of the proximal extension 208 may have a slightly larger perimeter than the proximal end 196 of the elongated housing member 192 so as to create an overhang or lip 226 that prevents the proximal extension 208 from entering the interior lumen 248 of the stabilizer tube 240. As a result, the proximal extension 208 is configured to “sit” on top of the stabilizer tube 240 when engaged thereto to provide a hard stop for advancement of the probe 190 through the stabilizer tube 240 and also maintain the proximal end 196 of the probe 190 in a fixed orientation relative to the stabilizer tube 240.
By way of example, the distal end 212 of the proximal extension 208 may further contain radiographic markers 228, 230 (see, e.g.,
In some embodiments, the probe 190 may be cannulated such that the probe 190 comprises an interior corridor (not shown) extending substantially the length of the elongated housing member 192 and configured to allow passage of one or more surgical instruments (e.g. K-wire 30) therethrough.
In some embodiments, the proximal end 244 of stabilizer tube 240 may further include (by way of example only) one or more surface markings 262 configured to indicate and identify the positions of the guide channels 116 of the dilator guide 26 irrespective of the instrument in use with the stabilizer tube 240 (e.g. probe 190, dilator guide 26, etc.). By way of example, the surface markings 262 may match the surface markings 232 on the probe 190 and comprise a numerical indication correlating to a specific guide channel 116 (e.g. a “1” to indicate the position of guide channel 116, a “2” to indicate the position of guide channel 116′, a “3” to indicate the position of guide channel 116″, and so forth). Similarly, the laterally extending flange 260 of the stabilizer tube 240 may further include (by way of example only) one or more surface markings 264 configured to indicate and identify the positions of the guide channels 116 of the dilator guide 26 irrespective of the instrument in use with the stabilizer tube 240 (e.g. probe 190, dilator guide 26, etc.). By way of example, the surface markings 264 may match the surface markings 232 on the probe 190 and surface markings 262 on the proximal end 244 and comprise a numerical indication correlating to a specific guide channel 116 (e.g. a “1” to indicate the position of guide channel 116, a “2” to indicate the position of guide channel 116′, a “3” to indicate the position of guide channel 116″, and so forth). This relationship is illustrated by way of example in
The first step of the exemplary method is to position the display unit 20 of the electronic device 14 within the primary user's field of vision within the O.R, but outside the sterile field. Typically, the primary user is the surgeon performing the surgery on the patient.
At this point the probe 12 (or probe 190 and/or any probe described herein) may be connected to the electronic device 14, for example by connecting cable 46 of the probe 12 to the communications module 306 of the electronic device 14. By way of example only, the connecting cable 46 may have a connector element that is securely received within a port on the electronic device 14, the port being in electronic communication with the communications module 306. In one embodiment, the port may have a locking feature to positively lock the connector element within the port.
Once the probe 12 has been connected to the electronic device 14, the probe 12 and stabilizer tube 24 may be coupled in preparation for insertion into the patient through the incision. To accomplish this, the transducer stabilizer 22 may be coupled to the probe 12 in the manner described above, and the probe 12 with coupled stabilizer 22 may be inserted into the interior lumen 96 of the stabilizer tube 24, for example such that the buttresses 80 of the stabilizer 22 are received within the interior lumen 96 of the stabilizer tube 24. The leading face 64 of the probe 12 should be in alignment with (or very nearly in alignment with) the distal aperture 104 to ensure as smooth a leading surface as possible during advancement through the patient's tissue.
As shown in
Once the leading face of the probe 64 is resting on the superficial psoas muscle, the probe assembly 438 may be registered to the operating table or bed 404 via a coupling with the articulating arm 424. As shown in
Referring to
The user may now use the software 18 of the intraoperative ultrasound probe system 10 to determine if any of the available pathways through the psoas (as determined by the positioning of the radiographic markers 86 on the stabilizer 22) are clear of nerves and/or vasculature, and are therefore suitable for dilator advancement. By way of example only,
At this point the user may tap on the “circle-I” icon 458 in the lower right corner of the GUI screen 440 to direct the computer to present a pop-up menu 460, shown on GUI screen 442 in
The pop-up menu 460 may further include a “shut down” icon 476 that when tapped by a user instructs the computer to begin the shutdown process, a “restart” icon 478 that when tapped by a user instructs the computer to restart the system, and a “Report” icon 480 that when selected by a user instructs the system to generate and store a session report to provide a record of the system events during the surgery. Each of the GUI screens 440, 442 (and any others) may also include a “camera” icon 482 that when selected by the user instructs the computer to capture and store a screenshot image, and a pull-down menu icon 484 that when selected by a user instructs the computer to present a pull-down menu that may present addition options for the user (for example including but not limited to login, surgery information, patient information, etc.)
If one or more of the indicated potential pathways 452, 454, 456 are determined to be clear of nerves, vasculature, and/or other structure to avoid and are therefore suitable for dilator advancement through the psoas, the guide number (e.g. 1, 2, 3, etc.) is noted for later use. If no pathway is determined to be suitably clear, then the probe assembly 438 may be repositioned and the process repeated until a suitable pathway is identified.
At this point, the surgeon may remove the probe 12 from the stabilizer tube 24 (which is held in place by the articulating arm 424), and engage in direct visualization (e.g. look with his/her eyes) down the interior lumen 96 of the conduit 24 to ensure that the planned dilation pathway is clear of the genitofemoral nerve, for example (and anything else that would be problematic). In some embodiments, an optical source (e.g., light source, camera, etc.) may be advanced through the stabilizer tube 24 to aid in direct visualization of the planned dilation pathway.
Next, the dilator guide 26 may be fully inserted into the stabilizer tube 24 as described above. A dilator 28 is then advanced through the guide channel 116 corresponding to the selected pathway (e.g. guide channels 116, 116′, 116″). The dilator 28 then advances through the psoas muscle along the selected pathway. A surgical guide wire 30 may then be inserted through the dilator 28 into the target disc space (see e.g.
After the dilator 28 and K-wire 30 are placed, the dilator guide 26 may be removed from the stabilizer tube 24, leaving the stabilizer tube 24, dilator 28 and K-wire 30 in place. The stabilizer tube 24 may then be decoupled from the articulating arm 424 and removed from the incision, leaving the dilator 28 and K-wire 30 in place (see, e.g.
Although the intraoperative ultrasound probe system 10 of the present disclosure is described herein as configured to facilitate navigation through tissue and neurovascular structure to determine an operative corridor to a surgical target site, in some embodiments the system 10 may be configured to locate and identify surgical implants (e.g., interbody implants, fixation plates, bone screws, rods, and the like), and differentiate between the surgical implants and anatomical structure. In such embodiments, the surgical implants may be modified or augmented to include one or more echogenic elements configured to reflect sound waves to make the surgical implants “visible” during ultrasound imaging. In some embodiments, the echogenic elements may comprise surface features including but not limited to (and by way of example only) notches, ridges, striations, and the like. In some embodiments, the surgical implants may be manufactured from echogenic material. By way of example only,
In some embodiments, the intraoperative ultrasound probe system 10 of the present disclosure may be configured to receive data collected through other modes, for example electromyography (EMG), integrate that data with ultrasound data, and display the combined data on the ultrasound image (e.g., as an additional overlay or an adjacent image) to create a confirmatory multi-modal display of the planned pathway and surrounding anatomical structures. By way of example only, a cannulated probe (e.g. cannulated probe 140 of
Referring to
The memory 604 stores information within the computing device 600. By way of example only, the memory 604 may be a volatile memory unit, non-volatile memory unit, or another form of computer-readable medium, such as a magnetic or optical disk (for example).
The storage device 606 is capable of providing mass storage for the computing device 600. In one implementation, the storage device 606 may be or contain a non-transitory computer-readable medium (e.g., any computer-readable media except transitory, propagating signals), such as a floppy disk device, a hard disk device, an optical disk device, or a tape device, a flash memory or other similar solid state memory device, or an array of devices, including devices in a storage area network or other configurations. A computer program product can be tangibly embodied in an information carrier. The computer program product may also contain instructions that, when executed, perform one or more methods, such as those described above. The information carrier is a computer- or machine-readable medium, such as the memory 604, the storage device 606, or memory on processor 602.
The high-speed interface 608 manages bandwidth-intensive operations for the computing device 600, while the low speed interface 612 manages lower bandwidth-intensive operations. Such allocation of functions is by way of example only. In one implementation, the high-speed interface 608 is coupled to memory 604, display 616 (e.g., through a graphics processor or accelerator), and to high-speed expansion ports 610, which may accept various expansion cards (not shown). In the implementation, low-speed interface 612 is coupled to storage device 606 and low-speed expansion port 614. The low-speed expansion port may include various communication ports (e.g., USB, Bluetooth, Ethernet, wireless Ethernet) and may be coupled to one or more input/output devices, such as a keyboard 618, a printer 620, a scanner 622, or a networking device such as a switch or router 624, e.g., through a network adapter.
The computing device 600 may be implemented in a number of different forms. For example, it may be implemented as a standard server, or multiple times in a group of such servers. It may also be implemented as part of a rack server system. In addition, it may be implemented in a personal computer such as a laptop computer. Alternatively, components from computing device 600 may be combined with other components in a mobile device, such as device 650 (
Referring to
The processor 652 can execute instructions within the computing device 650, including instructions stored in the memory 654. The processor may be implemented as a chipset of chips that include separate and multiple analog and digital processors. Additionally, the processor may be implemented using any of a number of architectures. For example, the processor 652 may be a CISC (Complex Instruction Set Computers) processor, a RISC (Reduced Instruction Set Computer) processor, or a MISC (Minimal Instruction Set Computer) processor. The processor may provide, for example, for coordination of the other components of the device 650, such as control of user interfaces, applications run by device 650, and wireless communication by device 650.
The processor 652 may communicate with a user through control interface 662 and display interface 664 coupled to a display 656. The display 656 may be, for example, a TFT (Thin-Film-Transistor Liquid Crystal Display) display or an OLED (Organic Light Emitting Diode) display, or other appropriate display technology. The display interface 664 may comprise appropriate circuitry for driving the display 656 to present graphical and other information to a user. The control interface 662 may receive commands from a user and convert them for submission to the processor 652. In addition, an external interface 666 may be provided in communication with processor 652, so as to enable near area communication of device 650 with other devices. External interface 666 may provide, for example, for wired communication in some implementations, or for wireless communication in other implementations, and multiple interfaces may also be used.
The memory 654 stores information within the computing device 650. The memory 654 can be implemented as one or more of a non-transitory computer-readable medium or media (e.g. as described above), a volatile memory unit or units, or a non-volatile memory unit or units. Expansion memory 668 may also be provided and connected to device 650 through expansion interface 670, which may include, for example, a SIMM (Single In Line Memory Module) card interface. Such expansion memory 668 may provide extra storage space for device 650, or may also store applications or other information for device 650. Specifically, expansion memory 668 may include instructions to carry out or supplement the processes described above, and may include secure information also. Thus, for example, expansion memory 668 may be provided as a security module for device 650, and may be programmed with instructions that permit secure use of device 650. In addition, secure applications may be provided via the SIMM cards, along with additional information, such as placing identifying information on the SIMM card in a non-hackable manner.
The memory may include, for example, flash memory and/or NVRAM memory, as discussed below. In one implementation, a computer program product is tangibly embodied in an information carrier. The computer program product contains instructions that, when executed, cause performance of one or more methods, such as those described above. The information carrier is a computer- or machine-readable medium, such as the memory 654, expansion memory 668, or memory on processor 652 that may be received, for example, over transceiver 660 or external interface 666.
Device 650 may communicate wirelessly through communication interface 658, which may include digital signal processing circuitry where necessary. Communication interface 658 may provide for communications under various modes or protocols, such as GSM voice calls, SMS, EMS, or MMS messaging, CDMA, TDMA, PDC, WCDMA, CDMA6000, or GPRS, among others. Such communication may occur, for example, through radio-frequency transceiver 660. In addition, short-range communication may occur, such as using a Bluetooth, WiFi, or other such transceiver (not shown). In addition, GPS (Global Positioning System) receiver module 672 may provide additional navigation- and location-related wireless data to device 650, which may be used as appropriate by applications running on device 650.
Device 650 may also communicate audibly using audio codec 674, which may receive spoken information from a user and convert it to usable digital information. Audio codec 674 may likewise generate audible sound for a user, such as through a speaker, e.g., in a handset of device 650. Such sound may include sound from voice telephone calls, may include recorded sound (e.g., voice messages, music files, etc.) and may also include sound generated by applications operating on device 650.
The computing device 650 may be implemented in a number of different forms, some of which are shown in the figure. For example, it may be implemented as a cellular telephone. It may also be implemented as part of a smart-phone, personal digital assistant, or other similar mobile device.
Additionally computing device 600 or 650 can include Universal Serial Bus (USB) flash drives. The USB flash drives may store operating systems and other applications. The USB flash drives can include input/output components, such as a wireless transmitter or USB connector that may be inserted into a USB port of another computing device.
Various implementations of the systems and techniques described here can be realized in digital electronic circuitry, integrated circuitry, specially designed ASICs (application specific integrated circuits), computer hardware, firmware, software, and/or combinations thereof. These various implementations can include implementation in one or more computer programs that are executable and/or interpretable on a programmable system including at least one programmable processor, which may be special or general purpose, coupled to receive data and instructions from, and to transmit data and instructions to, a storage system, at least one input device, and at least one output device.
These computer programs (also known as programs, software, software applications or code) include machine instructions for a programmable processor, and can be implemented in a high-level procedural and/or object-oriented programming language, and/or in assembly/machine language. As used herein, the terms “machine-readable medium” and “computer-readable medium” refer to any computer program product, apparatus and/or device (e.g., magnetic discs, optical disks, memory, Programmable Logic Devices (PLDs)) used to provide machine instructions and/or data to a programmable processor.
To provide for interaction with a user, the systems and techniques described here can be implemented on a computer having a display device (e.g., a CRT (cathode ray tube) or LCD (liquid crystal display) monitor) for displaying information to the user and a keyboard and a pointing device (e.g., a mouse or a trackball) by which the user can provide input to the computer. Other kinds of devices can be used to provide for interaction with a user as well; for example, feedback provided to the user can be any form of sensory feedback (e.g., visual feedback, auditory feedback, or tactile feedback); and input from the user can be received in any form, including acoustic, speech, or tactile input.
The systems and techniques described here can be implemented in a computing system that includes a back end component (e.g., as a data server), or that includes a middleware component (e.g., an application server), or that includes a front end component (e.g., a client computer having a graphical user interface or a Web browser through which a user can interact with an implementation of the systems and techniques described here), or any combination of such back end, middleware, or front end components. The components of the system can be interconnected by any form or medium of digital data communication (e.g., a communication network). Examples of communication networks include a local area network (“LAN”), a wide area network (“WAN”), peer-to-peer networks (having ad-hoc or static members), grid computing infrastructures, and the Internet.
The computing system can include clients and servers. A client and server are generally remote from each other and typically interact through a communication network. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other.
While the inventive features described herein have been described in terms of a preferred embodiment for achieving the objectives, it will be appreciated by those skilled in the art that variations may be accomplished in view of these teachings without deviating from the spirit or scope of the disclosure. Although the various components have been described in terms of a system, is should be noted that the several components may be used independently of other components. Furthermore, although shown and described herein with respect to a specific example, it should be understood that the principles of the disclosure are not limited to the specific example described herein, and that various modifications and improvements may be made without departing from the score of the disclosure. For example, in some embodiments a retractor may be used to stabilize the probe 12. In some embodiments, direct visualization of the dilator/K-wire placement may be utilized prior to removal of the stabilizer tube. In some embodiments, the system may include integration of three-dimensional soft tissue mapping capabilities enabled by image-guided navigation. In some embodiments, robotic automation may be employed to enhance precision and efficiency.
The present application is an international application claiming benefit of priority from commonly owned and co-pending U.S. Provisional Application Ser. No. 62/943,229 filed on Dec. 3, 2019 and entitled “INTRAOPERATIVE ULTRASOUND PROBE SYSTEM AND RELATED METHODS,” the entire contents of which is hereby incorporated by reference into this disclosure as if set forth fully herein.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US20/62949 | 12/2/2020 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 62943229 | Dec 2019 | US |
