Alignment systems and methods

Information

  • Patent Grant
  • 12196856
  • Patent Number
    12,196,856
  • Date Filed
    Thursday, April 28, 2022
    2 years ago
  • Date Issued
    Tuesday, January 14, 2025
    8 days ago
Abstract
Alignment systems and methods are disclosed. A system includes a first component and a second component. The first component has a first body supporting a first alignment member. The second component has a second body supporting a second alignment member. The first and second alignment members are separated from another and are configured to provide an indication that a fluoroscopic device is properly aligned with an anatomical plane when viewed under fluoroscopy. A method includes placing a first component supporting a first alignment member and a second component supporting a second alignment member relative to a patent, and aligning a fluoroscopic device with an anatomical plane using the first and second alignment members.
Description
FIELD OF DISCLOSURE

The disclosed systems and methods relate to the field of medical radiography. More particularly, the disclosed systems and methods relate to providing enhances visualization for ensuring that a prosthesis, fixture, and/or jig used in a surgical procedure is positioned properly.


BACKGROUND

Numerous surgical procedures use fluoroscopy to confirm a surgical plan and/or a placement of a surgical device, such as a fixture, prosthesis, and/or jig relative to a patient's anatomy. Ensuring proper alignment between a fluoroscopic device (e.g., an X-ray device supported by a C-arm) and an anatomical plane and/or surgical instrument is critical to ensuring that the information provided by fluoroscopy is accurate.


SUMMARY

In some embodiments, a system includes a first component and a second component. The first component has a first body supporting a first alignment member. The second component has a second body supporting a second alignment member. The first and second alignment members are separated from another and are configured to provide an indication that a fluoroscopic device is properly aligned with an anatomical plane when viewed under fluoroscopy.


In some embodiments, a method includes placing a first component supporting a first alignment member and a second component supporting a second alignment member relative to a patent, and aligning a fluoroscopic device with an anatomical plane using the first and second alignment members.


In some embodiments, a system includes an alignment device having a body defining a first aperture and a second aperture. The first and second apertures are disposed at an angle with one another. The first and second apertures are in communication with one another such that light passes through the first and second apertures when a fluoroscopic device is aligned with an anatomical plane.


In some embodiments, a method includes receiving light emitted from a light source in a first aperture defined by an alignment device, and directing the light from the first aperture defined by the alignment device to a second aperture defined by the alignment device such that light exits the alignment device from the second aperture. The second aperture is disposed at an angle with respect to the first aperture. The second aperture is disposed at an angle with respect to the first aperture.


In some embodiments, a system includes a first surgical device and an alignment adapted. The first surgical device is configured to be coupled to a patient. The alignment adapter has a body including a planar surface and a coupling mechanism for coupling the alignment adapter to the first surgical device such that the planar surface is parallel to an anatomical plane when the first surgical device is coupled to the patient and the alignment adapter is coupled to the first surgical device.


In some embodiments, a method includes placing a first surgical device relative to a patient, coupling an alignment device to the first surgical device, and aligning a fluoroscopic device with the planar surface of the alignment device. The alignment device includes a planar surface.





BRIEF DESCRIPTION OF THE DRAWINGS

The description of the exemplary embodiments disclosed herein are intended to be read in connection with the accompanying drawings, which are to be considered part of the entire written description. All drawing figures are schematic illustrations and are not intended to show actual dimensions or proportions.



FIG. 1A is a first side view of first and second components each having a respective alignment member in accordance with some embodiments;



FIG. 1B is a representation of the first and second components illustrated in FIG. 1A being viewed under fluoroscopy when there is a misalignment between the fluoroscopic device and the first and second components in accordance with some embodiments;



FIG. 1C is a representation of the first and second components illustrated in FIG. 1A being viewed under fluoroscopy when the fluoroscopic device is aligned properly with the first and second components in accordance with some embodiments;



FIG. 2A is a first side view of another example of first and second components each having a respective alignment member in accordance with some embodiments;



FIG. 2B is a representation of the first and second components illustrated in FIG. 2A being viewed under fluoroscopy when there is a misalignment between the fluoroscopic device and the first and second components in accordance with some embodiments;



FIG. 2C is a representation of the first and second components illustrated in FIG. 2A being viewed under fluoroscopy when the fluoroscopic device is aligned properly with the first and second components in accordance with some embodiments;



FIG. 3A is a first side view of another example of first and second components each having a respective alignment member in accordance with some embodiments;



FIG. 3B is a representation of the first and second components illustrated in FIG. 3A being viewed under fluoroscopy when there is a misalignment between the fluoroscopic device and the first and second components in accordance with some embodiments;



FIG. 3C is a representation of the first and second components illustrated in FIG. 3A being viewed under fluoroscopy when the fluoroscopic device is aligned properly with the first and second components in accordance with some embodiments;



FIG. 4 is a side view of one example of an alignment adapter in accordance with some embodiments;



FIG. 5A is a first side view of an alignment device in accordance with some embodiments;



FIG. 5B is a cross-sectional view of the alignment device illustrated in FIG. 5A taken along line 5B-5B in FIG. 5A positioned beneath a fluoroscopic device in accordance with some embodiments;



FIG. 5C is a cross-sectional view of the alignment device illustrated in FIG. 5A taken along line 5C-5C in FIG. 5A positioned beneath a fluoroscopic device in accordance with some embodiments; and



FIG. 5D is a cross-sectional view of the alignment device illustrated in FIG. 5A taken along line 5C-5C in FIG. 5A in use with another system in accordance with some embodiments.





DETAILED DESCRIPTION

This description of the exemplary embodiments is intended to be read in connection with the accompanying drawings, which are to be considered part of the entire written description. The drawing figures are not necessarily to scale, and certain features may be shown exaggerated in scale or in somewhat schematic form in the interest of clarity and conciseness. In the description, relative terms such as “horizontal,” “vertical,” “up,” “down,” “top” and “bottom” as well as derivatives thereof (e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should be construed to refer to the orientation as then described or as shown in the drawing figure under discussion. These relative terms are for convenience of description and normally are not intended to require a particular orientation. Terms including “inwardly” versus “outwardly,” “longitudinal” versus “lateral” and the like are to be interpreted relative to one another or relative to an axis of elongation, or an axis or center of rotation, as appropriate. Terms concerning attachments, coupling and the like, such as “connected” and “interconnected,” refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments or relationships, unless expressly described otherwise. When only a single machine is illustrated, the term “machine” shall also be taken to include any collection of machines that individually or jointly execute a set (or multiple sets) of instructions to perform any one or more of the methodologies discussed herein. The term “operatively connected” is such an attachment, coupling or connection that allows the pertinent structures to operate as intended by virtue of that relationship. In the claims, means-plus-function clauses, if used, are intended to cover the structures described, suggested, or rendered obvious by the written description or drawings for performing the recited function, including not only structural equivalents but also equivalent structures.


Fluoroscopy is commonly used during surgical procedures to ensure the proper alignment and/or orientation of prosthesis, fixture, and/or jig relative to a patient's anatomy. However, care must be taken to ensure that the fluoroscopic device (e.g., x-ray, C-arm) is properly aligned with the prosthesis, fixture, and/or jig.



FIG. 1A illustrates one example of a system 100 in accordance with some embodiments. In some embodiments, system 100 includes a first component 102 having a body 104 supporting a first alignment member 106. A second component 110 has a body 112 supporting a second alignment member 114. The bodies 104, 112 of the first and second components 102, 110 may be formed from a radiolucent material, including but not limited to polymers, PEEK, ABS, Nylon, etc., such that the bodies 104, 112 are invisible or only partially visible when viewed under fluoroscopy as will be understood by one of ordinary skill in the art. Although first and second components 102, 110 are shown as being separate components, it should be understood that the first and second components may be configured as first and second portions of a common device (e.g., the same prosthesis, fixture, and/or jig), but disposed at a distance from one another.


Further, although first and second components 102, 110 are described as each including a single alignment member, or parallax cues, i.e., alignment members 106, 114, first and second components 102, 110 may include plural alignment members, which may be oriented in the same or different planes. For example, first and second components 102, 110 may include one or more alignment members 106, 114 disposed in a first plane (e.g., coronal plane) and may also include one or more alignment members disposed in a second plane (e.g., sagittal or transverse plane). The alignment members may communicate position in 3D space while accounting for 2D fluoroscopy and inherent parallax in the image processing.


In some embodiments, the first and second alignment members 106, 114 are formed from a radiopaque material such that the first and second alignment members may be visualized under fluoroscopy. As seen in FIG. 1A, the first and second alignment members 106, 114 have the same shape and dimensions as one another for reasons discussed herein. Although the first and second alignment members 106, 114 are shown as having a circular or ring shape, it should be understood that the shape and size of the alignment members 106, 114 may vary. Further, the radiodensity (or radiopacity) of alignment members 106, 114 may be the same or different. Radiopaque materials may include metals, alloys, or other dense elements, such as titanium or tantalum.


The manner in which the first and second alignment members 106, 114 are supported by the first and second components 102, 110 also may vary. For example, the alignment members 106, 114 may be embedded within the respective bodies 104, 112 of the first and second components 102, 110. In some embodiments, the alignment members 106, 114 are affixed to a surface of the first and second components 102, 110, such as by using an adhesive or mechanical coupling. It should be understood that the first and second alignment members 106, 114 may be supported by the first and second components 102, 110 through different means. For example, the first alignment member 106 may be embedded within body 104 of first component 102, and second alignment member 114 may be affixed to a surface of body 112 of second component 110.



FIG. 1B illustrates one example of the system 100 being viewed under fluoroscopy when there is a misalignment between the fluoroscopic device (e.g., X-ray and/or C-arm) and an anatomical plane, and FIG. 1C illustrates one example of the system 100 being view under fluoroscopy when the fluoroscopic device (e.g., X-ray and/or C-arm) are aligned properly with an anatomical plane. As is apparent through a comparison of FIGS. 1B and 1C, the misalignment is identifiable when both alignment members 106, 114 are visible under fluoroscopy (FIG. 1B) and the fluoroscopic device is properly aligned with the system when the two alignment members 106, 114 appear as one (FIG. 1C).



FIG. 2A illustrates another example of a system in accordance with some embodiments. System 200 includes a first component 202 having a body 204 supporting a first alignment member 206. A second component 210 has a body 212 supporting a second alignment member 214. The bodies 204, 212 of the first and second components 202, 210 may be formed from a radiolucent material such that the bodies 204, 212 are invisible or only partially visible when viewed under fluoroscopy as will be understood by one of ordinary skill in the art. Although first and second components 202, 210 are shown as being separate components, it should be understood that the first and second components may be configured as first and second portions of a common device (e.g., the same prosthesis, fixture, and/or jig), but disposed at a distance from one another.


In some embodiments, the first and second alignment members 206, 214 are formed from a radiopaque material such that the first and second alignment members may be visualized under fluoroscopy. As seen in FIG. 2A, the first and second alignment members 206, 214 have different complementary shapes. More particularly, alignment member 206 is shown as being in the shape of a circle and alignment member 214 is shown as being in the shape of a crosshair that is dimensioned to correspond to the shape of alignment member 206. It should be understood that although alignment member 206 is illustrated as being a circle and alignment member 214 is illustrated as a crosshair, alignment members 206, 214 may have other shapes or configurations. For example, alignment member 206 may have another shape, such as a square, smaller ring, rectangle, triangle, etc., and/or alignment member 214 may take the form of a dot, circle, or other shape that is designed to provide an indication of alignment as will be understood by one of ordinary skill in the art. Further, the radiodensity (or radiopacity) of alignment members 206, 214 may be the same or different.


Although first and second components 202, 210 are described as each including a single alignment member, i.e., alignment members 206, 214, first and second components 202, 210 may include plural alignment members, which may be oriented in the same or different planes. For example, first and second components 202, 210 may include one or more alignment members 206, 214 disposed in a first plane (e.g., coronal plane) and may also include one or more alignment members disposed in a second plane (e.g., sagittal or transverse plane).


The manner in which the first and second alignment members 206, 214 are supported by the first and second components 202, 210 may also vary. For example, the alignment members 206, 214 may be embedded within the respective bodies 204, 212 of the first and second components 202, 210. In some embodiments, the alignment members 206, 214 are affixed to a surface of the first and second components 202, 210, such as by using an adhesive or mechanical coupling. It should be understood that the first and second alignment members 206, 214 may be supported by the first and second components 202, 210 through different means. For example, the first alignment member 206 may be embedded within body 204 of first component 202, and second alignment member 214 may be affixed to a surface of body 212 of second component 210.



FIG. 2B illustrates one example of the system 200 being viewed under fluoroscopy when there is a misalignment between the fluoroscopic device (e.g., X-ray and/or C-arm) and an anatomic plane, and FIG. 2C illustrates one example of the system 200 being view under fluoroscopy when the fluoroscopic device (e.g., X-ray, imaging device, and/or C-arm) is aligned properly with an anatomical plane. As is apparent through a comparison of FIGS. 2B and 2C, the misalignment is identifiable when alignment member 214 is not positioned properly with respect to alignment member 206, i.e., crosshair is not disposed within and encircled by the circle (FIG. 2B), and the fluoroscopic device is aligned properly with system 200 when alignment member 214 is disposed within and encircled by alignment member 206 (FIG. 2C).



FIG. 3A illustrates another example of a system in accordance with some embodiments. System 300 includes a first component 302 having a body 304 supporting a first alignment member 306. A second component 310 has a body 312 supporting a second alignment member 314. The bodies 304, 312 of the first and second components 302, 310 may be formed from a radiolucent material such that the bodies 304, 312 are invisible or only partially visible when viewed under fluoroscopy as will be understood by one of ordinary skill in the art. Although first and second components 302, 310 are shown as being separate components, it should be understood that the first and second components may be configured as first and second portions of a common device (e.g., the same prosthesis, fixture, and/or jig), but disposed at a distance from one another.


In some embodiments, the first and second alignment members 306, 314 are formed from a radiopaque material such that the first and second alignment members may be visualized under fluoroscopy. As seen in FIG. 3A, the first and second alignment members 306, 314 have different complementary shapes. More particularly, alignment member 306 is shown as being in the shape of a circle and alignment member 314 is shown as being a dot that is sized and configured to fill the entirety of the circle of alignment member 306. In some embodiments, the radiodensity (or radiopacity) of alignment members 306, 314 may be the same or different.


Further, although first and second components 302, 310 are described as each including a single alignment member, i.e., alignment members 306, 314, first and second components 302, 310 may include plural alignment members, which may be oriented in the same or different planes. For example, first and second components 302, 310 may include one or more alignment members 306, 314 disposed in a first plane (e.g., coronal plane) and may also include one or more alignment members disposed in a second plane (e.g., sagittal or transverse plane).


The manner in which the first and second alignment members 306, 314 are supported by the first and second components 302, 310 also may vary. For example, the alignment members 306, 314 may be embedded within the respective bodies 304, 312 of the first and second components 302, 210. In some embodiments, the alignment members 306, 314 are affixed to a surface of the first and second components 302, 310, such as by using an adhesive or mechanical coupling. It should be understood that the first and second alignment members 306, 314 may be supported by the first and second components 302, 310 through different means. For example, the first alignment member 306 may be embedded within body 304 of first component 302, and second alignment member 314 may be affixed to a surface of body 312 of second component 310.



FIG. 3B illustrates one example of the system 300 being viewed under fluoroscopy when there is a misalignment between the fluoroscopic device (e.g., X-ray and/or C-arm) and an anatomical plane, and FIG. 3C illustrates one example of the system 300 being view under fluoroscopy when the fluoroscopic device (e.g., X-ray, imaging device, and/or C-arm) aligned properly with an anatomical plane. As is apparent through a comparison of FIGS. 3B and 3C, the misalignment is identifiable when alignment member 314 is not positioned properly with respect to alignment member 306, i.e., dot is not disposed within and fill the circle (FIG. 3B), and the fluoroscopic device is aligned properly with system 300 when alignment member 314 is disposed within and fills alignment member 306 (FIG. 3C).



FIG. 4 illustrates another example of a system in accordance with some embodiments. More particularly, the alignment system provided in FIG. 4 includes an alignment adapter 402 that is sized and configured to engage another surgical device 30, such as the alignment guide 30 disclosed in U.S. Pat. No. 9,402,640, entitled “Alignment Guide with Embedded Features for Intra-Operative Fluoro-Checks,” which is incorporated by reference herein in its entirety.


Adapter 402 includes a body 404 that includes an enlarged planar surface 406 and a coupling mechanism 408. In some embodiments, planar surface 406 is enlarged with respect to the rest of the body 404 and provides for enhanced visualization such that the alignment between the surgical device 30 and the fluoroscopic device 50 may be checked or confirmed as described below. Coupling mechanism 408 may take a variety of forms to facilitate the coupling of adapter 402 to surgical device 30. For example and as depicted in FIG. 4, coupling mechanism 408 may the take the form of a channel 410 that is sized and configured to receive and/or engage at least a portion (e.g., the anterior protruding portion 36) of surgical device 30. It should be understood that the size and nature of coupling mechanism 408 may vary based on the characteristics of the device 30. Examples of other coupling mechanisms include, but are not limited to, a slot with dovetail connection, a detent, a hole for receiving a pin, and a protrusion designed to be inserted into a slot or hole defined by device 30, to list only a few possible examples.


Coupling mechanism 408 is designed to engage device 30 such that planar surface 406 is oriented relative to device 30 in a predetermined manner. For example, in some embodiments, coupling mechanism 408 is sized and configured to engage device 30 such that planar surface is parallel to a longitudinal axis of a radiopaque member (e.g., radiopaque members 34a, 34b, 35 disclosed in U.S. Pat. No. 9,402,640) supported by device 30.


With adapter 402 coupled to device 30, a surgeon, radiographic technician, or other individual may align the fluoroscopic device 50 with device 30 by visually determining whether the planar surface 406 of adapter 302 is oriented parallel to fluoroscopic device 50. The enlarged surface 406 provided by adapter 402 is easier to align with fluoroscopic device 50 compared to a surface feature of device 30. In some embodiments, adapter 402 and surgical device 30 may include cooperative alignment members, such as the alignment members described above with reference to FIGS. 1A-1C, 2A-2C, and 3A-3C.



FIGS. 5A-5C illustrates another example of an alignment device 500 in accordance with some embodiments. More particularly, FIG. 5A is a top side view of one example of an alignment device 500, FIG. 5B is a cross-sectional view of the device 500 taken along line 5B-5B in FIG. 5A, and FIG. 5C is a cross-sectional view of the device 500 taken along line 5C-5C in FIG. A.


Alignment device 500 has a body 502 that may be formed from a radiolucent material. In some embodiments, body 502 defines first and second apertures 504, 506 that are oriented at an angle with respect to one another. For example, apertures 504, 506 may be orthogonally oriented relative to one another such that aperture 504 is disposed parallel to a first plane (e.g., coronal, medial, sagittal, or transverse plane) and aperture 506 is disposed parallel to a second plane that is different from the first plane (e.g., another of the coronal, medial, sagittal, and transverse planes). However, it should be understood that apertures 504, 506 may be disposed at other angles (e.g., oblique or obtuse angles) relative to one another. As best seen in FIGS. 5B and 5C, apertures 504, 506 intersect one another within body 502.


In some embodiments, liners 508, 510 are disposed within apertures 504, 506, respectively. Liners 506, 508 may be formed from a reflective material and be configured to direct light 54, which is provided by a laser, light emitting diode (LED), or illuminating device 52, along their lengths. In some embodiments, the illuminating device 52 is supported by or coupled to an fluoroscopic device 50, which may be supported by or include a C-arm as will be understood by one of ordinary skill in the art.


In use, alignment device 500 is positioned either one a patient or coupled to another surgical instrument, such as a prosthetic, fixture, and/or jig. An illuminating device or light source 52, which is coupled to or provided by a C-arm and/or fluoroscopic device 50, directs light 54 into one of the apertures (e.g., aperture 504 as shown in FIGS. 5A-5C). When the fluoroscopic device is properly aligned with the device 500, the light 54 is received within aperture 504 (and liner 508, if provided) and is visible to the surgeon via aperture 506 (and liner 510, if provided). As noted above, the liners 508, 510 may reflect the light along their lengths to enable the light to be viewed by the surgeon, technician, or other individual 60 (FIG. 5C) and prevents the device 500 from being illuminated entirely by illuminating device 52.



FIG. 5D illustrates another system in which alignment device 500 may be included. As shown in FIG. 5D, a light source 52 directs light into aperture 506 (and liner 510, if provided) and a camera or optical sensor 56 is provided on the fluoroscopic device 50 (e.g., X-ray lens, C-arm, etc.) to detect light exiting aperture 504 (guided by liner 508, if provided). In some embodiments, the camera 56 is coupled to a control and image processing system 58, which may be configured to detect the light emanating from aperture 504 and move the C-arm and fluoroscopic device into position based on the light detected by camera or optical sensor 56. One example of a control and image processing system is imaging system 200 disclosed in U.S. Pat. No. 8,611,697, which is incorporated by reference herein in its entirety.


In some embodiments, a system includes a first component and a second component. The first component has a first body supporting a first alignment member. The second component has a second body supporting a second alignment member. The first and second alignment members are separated from another and are configured to provide an indication that a fluoroscopic device is properly aligned with an anatomical plane when viewed under fluoroscopy.


In some embodiments, the first component and the second component are respective portions of a common device.


In some embodiments, a shape of the first alignment member is the same as a shape of the second alignment member.


In some embodiments, a dimension of the first alignment member is the same as a dimension of the second alignment member.


In some embodiments, a radiopacity of the first alignment member is different from a radiopacity of the second alignment member.


In some embodiments, a shape of the first alignment member is different from a shape of the second alignment member.


In some embodiments, the shape of the first alignment member is complementary to the shape of the second alignment member.


In some embodiments, the shape of the first alignment member is circular.


In some embodiments, the second alignment member includes a crosshair.


In some embodiments, the shape of the second alignment member is a dot sized to fill an opening of the circular shape of the first alignment member.


In some embodiments, a method includes placing a first component supporting a first alignment member and a second component supporting a second alignment member relative to a patent, and aligning a fluoroscopic device with an anatomical plane using the first and second alignment members.


In some embodiments, aligning the fluoroscopic device with the anatomical plane includes viewing the first and second alignment members under fluoroscopy.


In some embodiments, the first and second alignment members appear as a single alignment member when the fluoroscopic device is aligned with the anatomical plane.


In some embodiments, the first and second alignment members have a complementary shape when the fluoroscopic device is aligned with the anatomical plane.


In some embodiments, a system includes an alignment device having a body defining a first aperture and a second aperture. The first and second apertures are disposed at an angle with one another. The first and second apertures are in communication with one another such that light passes through the first and second apertures when a fluoroscopic device is aligned with an anatomical plane.


In some embodiments, a first liner is disposed within the first aperture. The first liner is configured to direct light along a length of the first aperture.


In some embodiments, a second liner is disposed within the second aperture. The second liner is configured to direct light along a length of the second aperture.


In some embodiments, a system includes a light source configured to direct light into at least one of the first aperture and the second aperture.


In some embodiments, the light source is coupled to a C-arm of a radiographic device.


In some embodiments, a system includes an optical sensor coupled to a C-arm of a radiographic device. The optical detector is configured to detect light exiting at least one of the first aperture and the second aperture.


In some embodiments, a system includes a camera coupled to a C-arm of a radiographic device. The camera is configured to receive light from at least one of the first aperture and the second aperture.


In some embodiments, a method includes receiving light emitted from a light source in a first aperture defined by an alignment device, and directing the light from the first aperture defined by the alignment device to a second aperture defined by the alignment device such that light exits the alignment device from the second aperture. The second aperture is disposed at an angle with respect to the first aperture. The second aperture is disposed at an angle with respect to the first aperture.


In some embodiments, the light emitted from the light source is received within the first aperture when a fluoroscopic device is aligned with an anatomical axis.


In some embodiments, a method includes detecting light exiting the alignment device using an optical sensor.


In some embodiments, a method includes adjusting a position of a fluoroscopic device if light is not detected by the optical sensor.


In some embodiments, a method includes detecting light exiting the alignment device using a camera.


In some embodiments, a method includes adjusting a position of a fluoroscopic device if light is not detected by the camera.


In some embodiments, a system includes a first surgical device and an alignment adapted. The first surgical device is configured to be coupled to a patient. The alignment adapter has a body including a planar surface and a coupling mechanism for coupling the alignment adapter to the first surgical device such that the planar surface is parallel to an anatomical plane when the first surgical device is coupled to the patient and the alignment adapter is coupled to the first surgical device.


In some embodiments, the coupling mechanism includes a channel sized and configured to receive at least a portion of the first surgical device.


In some embodiments, the coupling mechanism includes a detent sized and configured to engage the first surgical device.


In some embodiments, the coupling mechanism includes a slot having a dovetail that is sized and configured to engage a corresponding feature of the first surgical device.


In some embodiments, a method includes placing a first surgical device relative to a patient, coupling an alignment device to the first surgical device, and aligning a fluoroscopic device with the planar surface of the alignment device. The alignment device includes a planar surface.


In some embodiments, a method includes adjusting a position of the fluoroscopic device until the fluoroscopic device is aligned with the planar surface of the alignment device.


In some embodiments, the planar surface of the alignment device is parallel to an anatomical plane of the patient.


Although the systems and methods have been described in terms of exemplary embodiments, they are not limited thereto. Rather, the appended claims should be construed broadly, to include other variants and embodiments of the systems and methods, which may be made by those skilled in the art without departing from the scope and range of equivalents.

Claims
  • 1. A system comprising: a first component having a first body supporting two or more first alignment members; anda second component having a second body supporting two or more second alignment members,wherein a first one of the two or more first alignment members and a first one of the two or more second alignment members are disposed in a first plane, and a second one of the two or more first alignment members and a second one of the two or more second alignment members are disposed in a second plane,wherein each of the two or more first alignment members are separated from each of the two or more second alignment members, andwherein the two or more first alignment members and the two or more second alignment members are configured to provide an indication that a fluoroscopic device is properly aligned with an anatomical plane and communicate position in 3D space when viewed under fluoroscopy.
  • 2. The system of claim 1, wherein the first component and the second component are respective portions of a common device.
  • 3. The system of claim 1, wherein a shape of the two or more first alignment members is the same as a shape of the two or more second alignment members.
  • 4. The system of claim 3, wherein a dimension of the two or more first alignment members is the same as a dimension of the two or more second alignment members.
  • 5. The system of claim 3, wherein a radiopacity of the two or more first alignment members is different from a radiopacity of the two or more second alignment members.
  • 6. The system of claim 1, wherein a shape of the two or more first alignment members is different from a shape of the two or more second alignment members.
  • 7. The system of claim 6, wherein the shapes of the two or more first alignment members are complementary to the shapes of the two or more second alignment members.
  • 8. The system of claim 7, wherein the shapes of the two or more first alignment members are circular.
  • 9. The system of claim 8, wherein the two or more second alignment members each comprise a crosshair.
  • 10. The system of claim 8, wherein the shapes of the two or more second alignment members are a dot sized to fill an opening of the circular shapes of the two or more first alignment members.
  • 11. A method, comprising: placing a first component supporting two or more first alignment members and a second component supporting two or more second alignment members relative to a patient,wherein a first one of the two or more first alignment members and a first one of the two or more second alignment members are disposed in a first plane, and a second one of the two or more first alignment members and a second one of the two or more second alignment members are disposed in a second plane to communicate position in 3D space when viewed under fluoroscopy, andwherein each of the two or more first alignment members are separated from each of the two or more second alignment members; andaligning a fluoroscopic device with an anatomical plane using the two or more first alignment members and the two or more second alignment members.
  • 12. The method of claim 11, wherein aligning the fluoroscopic device with the anatomical plane includes viewing the two or more first alignment members and the two or more second alignment members under fluoroscopy.
  • 13. The method of claim 12, wherein the first one of the two or more first and the first one of the two or more second alignment members disposed in the first plane appear as a single alignment member when the fluoroscopic device is aligned with the anatomical plane.
  • 14. The method of claim 12, wherein the two or more first alignment members and the two or more second alignment members have a complementary shape when the fluoroscopic device is aligned with the anatomical plane.
  • 15. A system, comprising: an alignment device having a body defining a first aperture and a second aperture, the first and second apertures being disposed at an angle with one another; anda fluoroscopic device spaced apart from the alignment device,wherein the first and second apertures are in communication with one another such that light passes through the first and second apertures when the fluoroscopic device is aligned with the alignment device disposed in an anatomical plane, andwherein the alignment device is configured to be positioned on a patient or coupled to a surgical instrument.
  • 16. The system of claim 15, wherein a first liner is disposed within the first aperture, the first liner configured to direct light along a length of the first aperture.
  • 17. The system of claim 16, wherein a second liner is disposed within the second aperture, the second liner configured to direct light along a length of the second aperture.
  • 18. The system of claim 17, further comprising a light source configured to direct light into at least one of the first aperture and the second aperture.
  • 19. The system of claim 18, wherein the light source is coupled to a C-arm of a radiographic device.
  • 20. The system of claim 18, further comprising an optical sensor coupled to a C-arm of a radiographic device, the optical sensor configured to detect light exiting at least one of the first aperture and the second aperture.
  • 21. The system of claim 18, further comprising a camera coupled to a C-arm of a radiographic device, the camera configured to receive light from at least one of the first aperture and the second aperture.
  • 22. A method, comprising: receiving light emitted from a light source in a first aperture defined by an alignment device positioned on a patient or coupled to a surgical instrument, the light source being spaced apart from the first aperture; anddirecting the light from the first aperture defined by the alignment device to a second aperture defined by the alignment device such that light exits the alignment device from the second aperture, the second aperture disposed at an angle with respect to the first aperture,wherein the directed light that exits the alignment device from the second aperture confirms alignment of the light source and the alignment device.
  • 23. The method of claim 22, wherein the light emitted from the light source is received within the first aperture when a fluoroscopic device is aligned with an anatomical axis.
  • 24. The method of claim 22, further comprising detecting light exiting the alignment device using an optical sensor.
  • 25. The method of claim 24, further comprising adjusting a position of a fluoroscopic device if light is not detected by the optical sensor.
  • 26. The method of claim 22, further comprising detecting light exiting the alignment device using a camera.
  • 27. The method of claim 26, further comprising adjusting a position of a fluoroscopic device if light is not detected by the camera.
  • 28. A system, comprising: a first surgical device configured to be coupled to a patient, the first surgical device supporting one or more first alignment members; andan alignment adapter having a body, the body including: a planar surface,a coupling mechanism for coupling the alignment adapter to the first surgical device such that the planar surface is parallel to an anatomical plane when the first surgical device is coupled to the patient and the alignment adapter is coupled to the first surgical device, andone or more second alignment members,wherein the one or more first alignment members and the one or more second alignment members are configured to provide an indication that a fluoroscopic device is properly aligned with an anatomical plane when viewed under fluoroscopy.
  • 29. The system of claim 28, wherein the coupling mechanism includes a channel sized and configured to receive at least a portion of the first surgical device.
  • 30. The system of claim 28, wherein the coupling mechanism includes a detent sized and configured to engage the first surgical device.
  • 31. The system of claim 28, wherein the coupling mechanism includes a slot having a dovetail that is sized and configured to engage a corresponding feature of the first surgical device.
  • 32. A method, comprising: placing a first surgical device relative to a patient, the first surgical device supporting one or more first alignment members;coupling an alignment device to the first surgical device, the alignment device including a planar surface and supporting one or more second alignment members; andaligning a fluoroscopic device with the planar surface of the alignment device, such that alignment of the one or more first alignment members and the one or more second alignment members provides an indication that the fluoroscopic device is properly aligned with an anatomical plane of a patient when viewed under fluoroscopy.
  • 33. The method of claim 32, further comprising adjusting a position of the fluoroscopic device until the fluoroscopic device is aligned with the planar surface of the alignment device.
  • 34. The method of claim 32, wherein the planar surface of the alignment device is parallel to an anatomical plane of the patient.
CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Application No. 63/208,572, filed Jun. 9, 2021, the entirety of which is incorporated by reference herein.

US Referenced Citations (228)
Number Name Date Kind
3839742 Link Oct 1974 A
3872519 Giannestras et al. Mar 1975 A
3886599 Schlein Jun 1975 A
3889300 Smith Jun 1975 A
3896502 Lennox Jul 1975 A
3896503 Freeman et al. Jul 1975 A
3975778 Newton, III Aug 1976 A
3987500 Schlein Oct 1976 A
4021864 Waugh May 1977 A
4069518 Groth, Jr. et al. Jan 1978 A
4156944 Schreiber et al. Jun 1979 A
4166292 Bokros Sep 1979 A
4204284 Koeneman May 1980 A
4232404 Samuelson et al. Nov 1980 A
4309778 Buechel et al. Jan 1982 A
4470158 Pappas et al. Sep 1984 A
4578806 Grass et al. Mar 1986 A
4755185 Tarr Jul 1988 A
4968316 Hergenroeder Nov 1990 A
5041139 Brånemark Aug 1991 A
5312412 Whipple May 1994 A
5326365 Alvine Jul 1994 A
5354300 Goble et al. Oct 1994 A
5423825 Levine Jun 1995 A
5476466 Barrette et al. Dec 1995 A
5601563 Burke et al. Feb 1997 A
5628749 Vendrely et al. May 1997 A
5634927 Houston et al. Jun 1997 A
5667511 Vendrely et al. Sep 1997 A
5674223 Cipolletti et al. Oct 1997 A
5735904 Pappas Apr 1998 A
5766259 Sammarco Jun 1998 A
5776200 Johnson et al. Jul 1998 A
5782842 Kloess et al. Jul 1998 A
5817097 Howard et al. Oct 1998 A
5824106 Fournal Oct 1998 A
5879389 Koshino Mar 1999 A
5885299 Winslow et al. Mar 1999 A
5888203 Goldberg Mar 1999 A
5897559 Masini Apr 1999 A
5935132 Bettuchi et al. Aug 1999 A
6002859 DiGioia, III et al. Dec 1999 A
6033405 Winslow et al. Mar 2000 A
6102952 Koshino Aug 2000 A
6183519 Bonnin et al. Feb 2001 B1
6245109 Mendes et al. Jun 2001 B1
6342056 Mac-Thiong et al. Jan 2002 B1
6344043 Pappas Feb 2002 B1
6409767 Pericéet al. Jun 2002 B1
6436146 Hassler et al. Aug 2002 B1
6478800 Fraser et al. Nov 2002 B1
6520964 Tallarida et al. Feb 2003 B2
6530930 Marino et al. Mar 2003 B1
6610067 Tallarida et al. Aug 2003 B2
6610095 Pope et al. Aug 2003 B1
6620168 Lombardo et al. Sep 2003 B1
6645215 McGovern et al. Nov 2003 B1
6663669 Reiley Dec 2003 B1
6673116 Reiley Jan 2004 B2
6679917 Ek Jan 2004 B2
6719799 Kropf Apr 2004 B1
6824567 Tornier et al. Nov 2004 B2
6852130 Keller et al. Feb 2005 B2
6860902 Reiley Mar 2005 B2
6863691 Short et al. Mar 2005 B2
6875222 Long et al. Apr 2005 B2
6875236 Reiley Apr 2005 B2
6926739 O'Connor et al. Aug 2005 B1
6939380 Guzman Sep 2005 B2
6942670 Heldreth et al. Sep 2005 B2
7001394 Gundlapalli et al. Feb 2006 B2
7011687 Deffenbaugh et al. Mar 2006 B2
7025790 Parks et al. Apr 2006 B2
7163541 Ek Jan 2007 B2
7238190 Schon et al. Jul 2007 B2
7252684 Dearnaley Aug 2007 B2
7314488 Reiley Jan 2008 B2
7323012 Stone et al. Jan 2008 B1
7476227 Tornier et al. Jan 2009 B2
7481814 Metzger Jan 2009 B1
7485147 Papps et al. Feb 2009 B2
7534246 Reiley et al. May 2009 B2
7534270 Ball May 2009 B2
7615082 Naegerl et al. Nov 2009 B2
7618421 Axelson, Jr. et al. Nov 2009 B2
7625409 Saltzman et al. Dec 2009 B2
7641697 Reiley Jan 2010 B2
7678151 Ek Mar 2010 B2
7713305 Ek May 2010 B2
7717920 Reiley May 2010 B2
7763080 Southworth Jul 2010 B2
7794144 Windt Sep 2010 B2
7803158 Hayden Sep 2010 B2
7850698 Straszheim-Morley et al. Dec 2010 B2
7896883 Ek et al. Mar 2011 B2
7896885 Miniaci et al. Mar 2011 B2
7909882 Stinnette Mar 2011 B2
7963996 Saltzman et al. Jun 2011 B2
8002841 Hasselman Aug 2011 B2
8012217 Strzepa et al. Sep 2011 B2
8034114 Reiley Oct 2011 B2
8034115 Reiley Oct 2011 B2
8048164 Reiley Nov 2011 B2
8083746 Novak Dec 2011 B2
8110006 Reiley Feb 2012 B2
8114091 Ratron et al. Feb 2012 B2
8167888 Steffensmeier May 2012 B2
8172850 McMinn May 2012 B2
8177841 Ek May 2012 B2
8268007 Barsoum et al. Sep 2012 B2
8303667 Younger Nov 2012 B2
8313492 Wong et al. Nov 2012 B2
8317797 Rasmussen Nov 2012 B2
8323346 Tepic Dec 2012 B2
8337503 Lian Dec 2012 B2
8361159 Ek Jan 2013 B2
8475463 Lian Jul 2013 B2
8491596 Long et al. Jul 2013 B2
8808303 Stemniski et al. Aug 2014 B2
8911444 Bailey Dec 2014 B2
9566075 Carroll et al. Feb 2017 B2
9672607 Demri et al. Jun 2017 B2
9901353 Carroll et al. Feb 2018 B2
9907561 Luna et al. Mar 2018 B2
10034678 Park et al. Jul 2018 B2
10039558 Park et al. Aug 2018 B2
10206688 Park et al. Feb 2019 B2
10433911 Wang et al. Oct 2019 B2
10722200 Kiraly Jul 2020 B2
20010053204 Navab Dec 2001 A1
20020068977 Jackson Jun 2002 A1
20020082607 Heldreth et al. Jun 2002 A1
20020133164 Williamson Sep 2002 A1
20020173853 Corl, III et al. Nov 2002 A1
20030208280 Tohidi Nov 2003 A1
20030236522 Long et al. Dec 2003 A1
20040030399 Asencio Feb 2004 A1
20040039394 Conti et al. Feb 2004 A1
20040068322 Ferree Apr 2004 A1
20040167631 Luchesi et al. Aug 2004 A1
20040186585 Feiwell Sep 2004 A1
20040216259 Ponziani Nov 2004 A1
20040236431 Sekel Nov 2004 A1
20050004676 Schon et al. Jan 2005 A1
20050165408 Puno et al. Jul 2005 A1
20050192674 Ferree Sep 2005 A1
20060009857 Gibbs et al. Jan 2006 A1
20060020345 O'Connor et al. Jan 2006 A1
20060036257 Steffensmeier Feb 2006 A1
20060116679 Lutz et al. Jun 2006 A1
20060142870 Robinson et al. Jun 2006 A1
20060235541 Hodorek Oct 2006 A1
20060247788 Ross Nov 2006 A1
20070038303 Myerson et al. Feb 2007 A1
20070100346 Wyss et al. May 2007 A1
20070112431 Kofoed May 2007 A1
20070162025 Tornier et al. Jul 2007 A1
20070173944 Keller et al. Jul 2007 A1
20070173947 Ratron Jul 2007 A1
20070203455 Tremaglio, Jr. et al. Aug 2007 A1
20070213830 Ammann et al. Sep 2007 A1
20070233129 Bertagnoli et al. Oct 2007 A1
20070276400 Moore et al. Nov 2007 A1
20070288030 Metzger et al. Dec 2007 A1
20080015602 Axelson Jan 2008 A1
20080097617 Fellinger et al. Apr 2008 A1
20080103603 Hintermann May 2008 A1
20080109081 Bao et al. May 2008 A1
20080195233 Ferrari et al. Aug 2008 A1
20080215156 Duggal et al. Sep 2008 A1
20080287954 Kunz et al. Nov 2008 A1
20080312745 Keller et al. Dec 2008 A1
20090024131 Metzger et al. Jan 2009 A1
20090043310 Rasmussen Feb 2009 A1
20090054992 Landes et al. Feb 2009 A1
20090082875 Long Mar 2009 A1
20090105767 Reiley Apr 2009 A1
20090105840 Reiley Apr 2009 A1
20090182433 Reiley et al. Jul 2009 A1
20090198341 Choi et al. Aug 2009 A1
20090234360 Alexander Sep 2009 A1
20090276052 Regala et al. Nov 2009 A1
20100010493 Dower Jan 2010 A1
20100023066 Long et al. Jan 2010 A1
20100023126 Grotz Jan 2010 A1
20100057216 Gannoe et al. Mar 2010 A1
20100069910 Hasselman Mar 2010 A1
20100198355 Kofoed et al. Aug 2010 A1
20100241237 Pappas Sep 2010 A1
20100305572 Saltzman et al. Dec 2010 A1
20100318088 Warne et al. Dec 2010 A1
20100331984 Barsoum et al. Dec 2010 A1
20110029090 Zannis et al. Feb 2011 A1
20110035018 Deffenbaugh et al. Feb 2011 A1
20110035019 Goswami et al. Feb 2011 A1
20110106268 Deffenbaugh et al. May 2011 A1
20110125200 Hanson et al. May 2011 A1
20110125275 Lipman et al. May 2011 A1
20110125284 Gabbrielli et al. May 2011 A1
20110152868 Kourtis et al. Jun 2011 A1
20110152869 Ek et al. Jun 2011 A1
20110166608 Duggal et al. Jul 2011 A1
20110190829 Duggal et al. Aug 2011 A1
20110218542 Lian Sep 2011 A1
20110249793 Lalena Oct 2011 A1
20110253151 Tochigi et al. Oct 2011 A1
20110276052 Hasselman Nov 2011 A1
20110295380 Long Dec 2011 A1
20120010718 Still Jan 2012 A1
20120046753 Cook et al. Feb 2012 A1
20120053644 Landry et al. Mar 2012 A1
20120083789 Blakemore et al. Apr 2012 A1
20120109131 Vasarhelyi et al. May 2012 A1
20120109326 Perler May 2012 A1
20120130376 Loring et al. May 2012 A1
20120136443 Wenzel May 2012 A1
20120185057 Abidi et al. Jul 2012 A1
20120191210 Ratron et al. Jul 2012 A1
20120239045 Li Sep 2012 A1
20120245701 Zak et al. Sep 2012 A1
20120271430 Arnett et al. Oct 2012 A1
20120277745 Lizee Nov 2012 A1
20130041473 Rouyer et al. Feb 2013 A1
20130116797 Coulange et al. May 2013 A1
20140275955 Crawford et al. Sep 2014 A1
20160135815 Loring et al. May 2016 A1
20190209080 Gullotti et al. Jul 2019 A1
20210405378 Choi Dec 2021 A1
Foreign Referenced Citations (30)
Number Date Country
2836651 Mar 2016 CA
19501069 Jul 1996 DE
2967697 Apr 2018 EP
3607898 Aug 2021 EP
2480846 Dec 2011 GB
H11-500035 Jan 1999 JP
2006150055 Jun 2006 JP
2007518453 Jul 2007 JP
2007519477 Jul 2007 JP
2007536011 Dec 2007 JP
2011526189 Oct 2011 JP
2012518517 Aug 2012 JP
2013500810 Jan 2013 JP
2013511358 Apr 2013 JP
2014131738 Jul 2014 JP
WO 9625106 Aug 1996 WO
WO 0166021 Sep 2001 WO
WO 2005011523 Feb 2005 WO
WO 2006022923 Mar 2006 WO
WO 2006023824 Mar 2006 WO
WO 2006099270 Sep 2006 WO
WO 2007084846 Jul 2007 WO
WO 2009158522 Dec 2009 WO
WO 2010099142 Sep 2010 WO
WO 2011015863 Feb 2011 WO
WO 2011063281 May 2011 WO
WO 2011151657 Dec 2011 WO
WO 2012088036 Jun 2012 WO
WO 2012116089 Aug 2012 WO
2020124047 Jun 2020 WO
Non-Patent Literature Citations (17)
Entry
Anonymous: “Angle bracket (fastener)—Wikipedia”, May 22, 2021, 1 page.
Extended European Search Report issued in connection with European U.S. Appl. No. 22/172,072, filed May 4, 2023, 25 pages.
Anonymous: Newtonian Telescope—Wikipedia, May 23, 2021, 6 pages.
Anonymous: “Light Tube—Wikipedia”, Mar. 4, 2021, 11 pages.
Search report issued for European patent application No. 13198280 dated Feb. 5, 2014.
International Search Report for International patent application No. PCT/US2014/027448 dated Jul. 7, 2014.
International Preliminary Report on Patentability issued for International patent application No. PCT/US2014/027448, Sep. 15, 2015, 8 pages.
Partial European Search Report issued in connection with European patent application No. 14768333.8, Oct. 26, 2016, 6 pages.
Patent Examination Report No. 1 issued in connection with Australian patent application No. 2015202080, Jul. 5, 2016, 4 pages.
Office Action in corresponding Canadian Patent Application No. 2,904,652, Jun. 2, 2020, 6 pages.
First Examination Report issued in corresponding Australian Patent Application No. 2019213412, Sep. 3, 2020, 5 pages.
First Office Action in corresponding Canadian Patent Application No. 2,904,652, Jan. 28, 2020, 5 pages.
Final Office Action issued in connection with corresponding Japanese Patent Application No. 206-502443, May 15, 2018, 3 pages.
Extended European Search Report issued in connection with corresponding European Patent Application No. 18160378.8, Jun. 29, 2018, 7 pages.
Examination Report No. 1 issued in connection with corresponding Australian Patent Application No. 20182000073, Dec. 24, 2018, 3 pages.
Extended European Search Report and Opinion in connection with European Patent Application No. 14768333.8, dated Jan. 30, 2017, 10 pages.
Partial European Search Report issued in connection with Application No. 22172072.5, Jan. 23, 2023, 18 pages.
Related Publications (1)
Number Date Country
20220397670 A1 Dec 2022 US
Provisional Applications (1)
Number Date Country
63208572 Jun 2021 US