Surgical device for use with surgical tool

Abstract

A surgical device is disclosed that is attached to a body of a surgical tool that can be used to manipulate intended tissue in a surgical site in a patient. The surgical device may include a housing having at least one of a projection device, an imaging device, and / or an illumination device disposed thereon. The housing may be removably attached to the body in a surgical alignment direction relative to the body. One or more projection devices may emit optical localization indicia onto the surgical site from the exit port in a localization direction. One or more illumination devices may illuminate the surgical site. One or more imaging devices may acquire an image of a surgical site.

Description

Technical Field

[0001] The present disclosure relates generally to surgical tools for manipulating tissue in a surgical site of a patient and, more particularly, to surgical devices attachable to such surgical tools to provide positioning guidance and / or visualization of the surgical site. Background Art

[0002] Surgical tools have been developed to operate (i.e., change, cut, remove or destroy) tissue in the expected area within the surgical site during medical or dental surgery. Such tools can use contact structures (e.g., grinders, tweezers, clamps, jaws and blades) or non-contact structures (e.g., lasers) to achieve such operations. Therefore, surgical tools use means such as ultrasonic vibration, oscillating motion, rotational motion, laser energy, electrical energy, mechanical force, electromagnetic energy, magnetic energy, radiofrequency energy, radioactivity, chemical energy or reactants, mechanical energy and thermal energy to operate tissue to achieve the desired surgical results. Whether as part of a surgical tool or as part of a separate insertion tool, an additional catheter can be used to provide fluid to flush and / cool the surgical site, and / or take away blood or removed / destroyed tissue from the surgical site.

[0003] When performing such a surgical procedure, the surgeon needs information about the position and alignment of the surgical tools, about the characteristics and operating elements of the tools, and about the orientation of the tools relative to the tissue in the surgical site. Such information needs exist whether the tools are operated directly by the surgeon or by a robot.

[0004] If a given surgical procedure is such that the wound cavity at the surgical site is open, the surgeon can obtain such information by direct visual observation of the surgical tools and the surgical site. If the surgical procedure is such that the surgeon cannot directly see the target tissue, other indirect visualization methods may be used, such as inserting a camera on a tool separate from the surgical tools into the surgical site, performing X-ray imaging or magnetic resonance imaging of the surgical site on the patient, etc. The indirect visualization method selected depends on factors such as the surgical location, the size and characteristics of the wound cavity, the tools and techniques used, and the surgeon's preference.

[0005] Indirect visualization is typically achieved using an additional optical tool (e.g., an endoscope) that emits a broad beam of illumination to the surgical site and uses a camera to view the tool and the surgical site. Conventional endoscopes provide a two-dimensional, non-stereoscopic view in which the alignment of the tool with the tissue and / or the point of contact of the tool with the tissue is inferred. Therefore, the precision of the surgery depends primarily on the surgeon's ability to determine the position of the tool within the surgical site based on experience and training. In addition, the use of a conventional endoscope allows the surgeon to observe the surgical procedure only from the perspective of the endoscope (i.e., from the viewpoint of the position of the camera lens on the endoscope), and not from a relative "third person" perspective (i.e., from a viewpoint different from the viewpoint provided by the camera lens on the endoscope, or from a movable viewpoint).

[0006] Non-powered surgical tools (including but not limited to retractors, forceps, dilators, cutters, etc.) may also be used in surgical or dental procedures where precise aiming, positioning, or orientation information is important. Therefore, the concerns and challenges described above regarding the use of powered surgical tools also apply to many non-powered tools.

[0007] While existing surgical tools and methods have been successful and adequate for their intended purposes, improvements in surgical tools and methods that provide positioning and visualization information to the surgeon are still welcome, particularly as they relate to more delicate and minimally invasive surgical procedures. Summary of the invention

[0008] According to certain aspects of the present disclosure, a surgical device is disclosed, which is attached to the body of a surgical tool, and the surgical tool can be used to operate the intended tissue in the surgical site of the patient's body. The surgical device includes, for example: a shell, which is configured to be detachably attached to the body along the surgical alignment direction relative to the body; an illumination device, which is disposed on the shell and is used to illuminate the surgical site; and at least one imaging device, which is used to obtain an image of the surgical site illuminated by the illumination device. At least one imaging device includes an optical receiver, which is attached to the shell and is used to obtain an image of the surgical site. Various options and modifications are possible.

[0009] For example, at least one imaging device includes a camera that receives images from an optical receiver. At least one imaging device may use multiple optical receivers, and multiple images acquired by the multiple optical receiver devices are complementary to each other. The display device may provide a display of the images acquired by the at least one imaging device. The display may include virtual positioning marks that are overlaid on the image of the surgical site to provide information related to at least one of the position, orientation, and distance of the surgical tool relative to the surgical site. The display device may be separated from the housing and the main body and located outside the patient's body for viewing by the user of the tool. The lighting device may include at least one LED. The housing may be connected to a power source that is used to power multiple elements attached to the housing. The housing may be fixed to the outer surface of the main body at least mechanically, chemically, or magnetically.

[0010] A projection device may be added, the projection device having an emission port, the emission port being located on the housing, and when the housing is located on the main body along the surgical alignment direction, the projection device may be powered to emit an optical positioning mark from the emission port along the positioning direction to the surgical site, the optical positioning mark providing information about at least one of the position and orientation of the main body of the surgical tool within the surgical site, and at least one imaging device capable of imaging the optical positioning mark. The projection device may include at least one LED and a laser to generate one or more optical positioning marks.

[0011] According to other aspects of the present disclosure, a surgical device is disclosed, which is attached to the body of a surgical tool, and the surgical tool can be used to operate the intended tissue in the surgical site of the patient. The surgical device includes, for example: a shell, which is configured to be detachably attached to the body along the surgical alignment direction relative to the body; at least one imaging device, at least one imaging device is used to obtain an image of the surgical site, at least one imaging device includes an optical receiver and a camera, the optical receiver is attached to the shell and is used to obtain an image of the surgical site, and the camera is used to receive the image from the optical receiver; and a display device, the display device is used to provide a display of the image obtained by the at least one imaging device. The display includes a virtual positioning mark, which is overlaid on the image of the surgical site to provide information related to at least one of the position, orientation and distance of the surgical tool relative to the surgical site. As described above, various options and modifications are possible.

[0012] For example, at least one imaging device may use multiple optical receivers, and the multiple images acquired by the multiple optical receiver devices are complementary to each other. The lighting device may be arranged on the housing and used to illuminate the surgical site. The housing may be connected to a power source, and the power source is used to power multiple elements attached to the housing. The housing may be fixed to the main body at least mechanically, geometrically, chemically or magnetically. The projection device may be provided with an emission port, which is located on the housing and is used to emit an optical positioning mark from the emission port along the positioning direction to the surgical site when the housing is located on the main body along the surgical alignment direction. The optical positioning mark can be detected by the imaging device and can be displayed on the display of the image. The projection device may include at least one LED and a laser to generate one or more optical positioning marks. The display device may be spaced apart from the housing and the main body and located outside the patient's body for viewing by the user of the tool. The lighting device may include at least one LED.

[0013] According to other aspects of the present disclosure, a surgical device is disclosed, which is attached to the body of a surgical tool, and the surgical tool can be used to operate the intended tissue in the surgical site of the patient's body. The surgical device includes, for example: a shell, which is configured to be detachably attached to the body along the surgical alignment direction relative to the body; and a projection device, which has an emission port, and the emission port is located on the shell. When the shell is located on the body along the surgical alignment direction, the projection device can be powered to emit an optical positioning mark from the emission port along the positioning direction to the surgical site, and the optical positioning mark provides information related to at least one of the position and orientation of the body of the surgical tool in the surgical site. Again, various options and modifications are possible.

[0014] For example, the housing can be fixed to the body at least mechanically, geometrically, chemically or magnetically. The housing can be connected to a power source, which is used to power the projection device. The device can also include an illumination device, which is arranged on the housing and is used to illuminate the surgical site, and the illumination device is at least one LED, and the at least one LED is arranged on the housing adjacent to the emission port. The illumination device and the projection device can be connected to a power source. At least one imaging device can be provided, and the at least one imaging device is used to obtain an image of the surgical site. The at least one imaging device includes an optical receiver and a camera, the optical receiver is attached to the housing and is used to obtain an image of the surgical site, and the camera is used to receive the image from the optical receiver. The projection device can include an electric light source, and the emission port includes a lens, and the lens is used to guide the light from the electric light source in the form of a beam to the positioning direction to form an optical positioning mark. The projection device can include a laser, and the emission port can include a lens, and the lens is used to guide the laser from the laser to the positioning direction to form an optical positioning mark. The laser can emit visible laser or infrared laser. The surgical device also includes: at least one imaging device, at least one imaging device is used to obtain images of the surgical site, at least one imaging device includes an optical receiver and a camera, the optical receiver is attached to the shell and is used to obtain images of the surgical site including optical positioning marks, the camera is used to receive images from the optical receiver; and a display device, the display device is used to provide a display of the image including the optical positioning mark obtained by the at least one imaging device.

[0015] A kit may be provided, the kit comprising the surgical device of any of the above embodiments, a surgical tool, and an attachment and / or connection structure for attaching the device to the tool. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 is an isometric view of a surgical tool according to certain aspects of the present disclosure.

[0017] Figure 2A yes Figure 1 A close-up side view of the distal portion of the tool is shown, the distal portion having a distally directed projection.

[0018] Figure 2B yes Figure 1 A close-up top view of the distal portion of the tool is shown.

[0019] Figure 3 is an isometric diagram showing a surgeon using Figure 1 The tool is shown with direct visual observation of the optical positioning markers projected on the surgical site.

[0020] Figure 4Ais a schematic view of one possible system for projecting optical positioning markers from a tool and optionally for acquiring an image of a surgical site using an optical unit of the tool.

[0021] Figure 4B yes Figure 4A Schematic representation of the individual components of the optical unit shown.

[0022] Figure 5 is a schematic view showing optical positioning markers and other optional markers projected on the surgical site by the projection device and imaging device on the tool as visually viewed by the surgeon on a display from a first-person perspective.

[0023] Fig. 6A and Figure 6B 2 are schematic side views, respectively showing multiple possible orientations and parallel projections of projected positioning markers of the tool when the tool moves from a first distance to a second distance (ie, contact) relative to the surgical site.

[0024] Fig. 7A and Figure 7B 2 are schematic side views, respectively illustrating multiple possible orientations and non-parallel projected positioning marks of the tool when the tool is moved from a first distance to a second distance (ie, contact) relative to the surgical site.

[0025] Fig. 8A and Figure 8B are schematic isometric views respectively illustrating multiple possible orientations of the tool and non-linear (conical) projected positioning markers as the tool moves from a first distance to a second distance (ie, contact) relative to the surgical site.

[0026] Fig. 9 is a close-up side view of an alternative distal portion of the tool having four distally-oriented projection devices for projecting four spaced-apart optical positioning markers.

[0027] Fig.10 is a schematic isometric view showing a tool having four optical positioning marks provided by a Fig. 9 The distal portion of the tool is shown projecting four optical positioning markers distributed around and equidistantly spaced from the intended contact point.

[0028] Fig.11A and Fig. 11B are simplified isometric views showing multiple possible orientations of the tool and four distally directed and parallel projected positioning markers as the tool moves from a first distance to a second distance (ie, contact) relative to the surgical site.

[0029] Fig. 11C is a schematic side view of a plurality of projected locator marks including letters or other symbolic indicators to indicate intended contact points.

[0030] Fig.11D is a schematic side view of a plurality of projected positioning marks including a plurality of lines (crosshairs) to indicate intended contact points.

[0031] Fig. 12A and Fig. 12B 2 are schematic side views, respectively showing multiple possible orientations of the tool and distally and non-parallel projected upper and lower positioning markers as the tool moves from a first distance to a second distance (i.e., contact) relative to the surgical site.

[0032] Fig.13A and Fig. 13B are schematic side views respectively illustrating multiple possible orientations of a tool having two exit ports emitting separate light beams in orthogonal directions as the tool moves from a first distance to a second distance (ie, contact) relative to a surgical site.

[0033] Fig.14A is a close-up side view of an alternative distal portion of a tool having a distal protective shield and four laterally oriented and parallel projecting projection devices (for projecting four spaced apart optical positioning markers) and having an imaging device thereon.

[0034] Fig. 14B yes Fig.14A A close-up front view of the distal portion of the tool is shown.

[0035] Fig.15 is an isometric diagram showing a surgeon using a Fig.14A The distal portion of the tool is shown with direct visual observation of multiple optical positioning markers projected onto the surgical site.

[0036] Fig.16 is a schematic view showing a plurality of optical positioning markers projected on a surgical site as visually viewed by a surgeon on a display generated by an imaging device.

[0037] Fig.17 It can be used Figure 1-16 Schematic views of various systems of tools and various related components are shown.

[0038] Fig.18 is a schematic isometric view of one embodiment of a surgical device attached to a surgical tool according to certain aspects of the present disclosure.

[0039] Fig.19 yes Fig.18 A schematic side view of a surgical device is shown with the surgical device attached at a distal end to a powered surgical tool.

[0040] Fig. 20 yes Fig.19 Schematic end view of a surgical device and surgical tools shown.

[0041] Fig.21 yes Fig.19 Schematic top view of the surgical apparatus and surgical tools shown.

[0042] Fig. 22 is a schematic distal isometric view of an alternative surgical device attachable to a surgical tool via a mechanical / geometric attachment according to certain other aspects of the present disclosure.

[0043] Fig.23 yes Fig. 22 A schematic proximal isometric view of the contralateral side of the surgical device is shown.

[0044] Fig.24 yes Fig. 22 A schematic side view of a surgical device is shown attached to a non-powered surgical tool.

[0045] Fig.25 yes Fig. 22 A schematic close-up isometric view of a portion of a surgical device and tool is shown.

[0046] Fig.26 yes Fig. 22 A schematic proximal isometric view of a modified version of the surgical device is shown in which a cuff is used in place of the mechanical / geometric attachment structure. DETAILED DESCRIPTION

[0047] Reference will now be made in detail to the accompanying drawings, in which examples of implementing the present disclosure are shown. The detailed description uses numbers and letter labels to refer to features in the drawings. Like or similar reference numerals in the drawings and description are used to refer to like or similar parts of the present disclosure.

[0048] The accompanying drawings and detailed description provide a complete and enabling description of the disclosure and the manner and process of making and using the same. Each embodiment is provided to illustrate the subject matter and not to limit it. In fact, it will be apparent to those skilled in the art that various modifications and variations may be made to the disclosed subject matter without departing from the scope or spirit of the disclosure. For example, features shown or described as part of one embodiment may be used with another embodiment to produce yet another embodiment.

[0049] The present disclosure generally relates to embodiments and aspects of power surgical tools that can be used to perform surgical procedures on the human or animal body. The examples discussed below are exemplary only and should not be considered limiting. The examples discussed below integrate optical properties onto surgical tools, including one or more projection devices and / or one or more imaging devices. The disclosed projection devices are not only lighting devices, but are also configured to assist in performing at least one of the following operations: positioning surgical tools, visualization, determining and / or indicating the distance between the tool and the intended (target) tissue, so as to operate the surgical site and / or wound cavity. The disclosed imaging device is configured to assist in visualization. Certain aspects of the following examples provide first-person perspective visualization from the viewpoint of the tissue operating member of the surgical tool. Other aspects provide the projection of one or more positioning marks to guide the surgeon and assist in tool alignment, and determine and / or indicate the distance between the operating member of the tool and the tissue. A further aspect is to provide predetermined alignment marks on the surgical tool to assist in determining the position and orientation of the surgical tool. These tools can be used for medical or dental surgery, or surgery performed on any part of the human body by medical / dental professionals, or surgery performed on the animal body by veterinary professionals. The use of "surgeon" mentioned herein is for convenience only, and it should be understood that such a user may be any type of medical professional, such as a doctor, dentist, oral surgeon, specialist, assistant, veterinarian, etc., and the power surgical tool is configured to be performed by such a person in a direct, cooperative or robotic manner for a specific purpose. Therefore, the power surgical tools described and claimed herein include, but are not limited to, any type of power tool used by any person when performing any such surgical procedure on the human or animal body. Other aspects of the present disclosure are set forth in detail below and / or listed in the following claims.

[0050] According to certain aspects of the present disclosure, Figure 1-6B A first embodiment of a powered surgical tool is shown that is capable of generating optical positioning marks for assisting a user in positioning the tool to manipulate target tissue. It should be understood that the specific disclosed aspects of the tool are merely exemplary and that many types of surgical tools may be used with one or more of the disclosed optical positioning features or functions based on the present disclosure. In addition, Figure 1-6B The embodiments include several optional features, all of which are not required in any one particular tool according to the present disclosure in order to enjoy certain beneficial aspects of the present disclosure.

[0051] like Figure 1As shown, the tool 20 includes a body 22, the body 22 has a central portion 24, and one or more cables 26a, 26b, 26c are attached to the central portion 24 to provide power, control signals and / or optical communication functions to the tool, or to provide power, control signals and / or optical communication functions from the tool. One or more optional additional conduits 28a, 28b can be provided to achieve other functions, such as providing flushing fluid to the surgical site and aspirating fluid and material from the surgical site. As described below, multiple cables and multiple conduits can be connected to one or more other components of the surgical system. More or fewer cables or conduits can be used. For example, if necessary, all or some cables, all or some conduits, or all cables and conduits can be located in a sheath or the like, so as to simplify or more compactly connect the tool to the rest of the system. In addition, if necessary, wireless communication devices can be used instead of cables carrying electronic components, signal transmission, etc.

[0052] The tissue manipulation portion 30 is attached to the body 22. If desired, the manipulation portion 30 can be removably attached to the central portion 24 of the body by a connecting portion 32. In this case, the body 20 can be used in a modular manner with different types of manipulation members, whether provided together as a kit or separately. In addition, the manipulation portion 30 can be removable for cleaning and reuse, or in a disposable embodiment, the manipulation portion 30 can be removable and can be discarded.

[0053] like Figure 1 As shown, the tissue manipulation portion 30 is attached to the central portion 24 of the body 22 at the distal end, and the manipulation member 34 of the manipulation portion 30 further extends distally to form the end of the tool 20. Figure 1 In the example shown, the operating portion 30 and its operating member 34 extend linearly along the central axis 36, but it should be understood that other linear, curvilinear or angled shapes, whether regular or irregular, are feasible. In addition, the operating member 34 is not necessarily located at the distal end of the operating portion 30 and / or the tool 20, and more than one operating portion or an operating portion with more than one exposed portion can be used.

[0054] As shown, the operating member 34 is a conventional mechanical rotating abrasive that destroys tissue by direct contact when rotating. It should be understood that in addition to mechanical and / or rotating members, other types of operating members can also be used in the tool 20. Therefore, as used herein, "operation" can be any type of change, cutting, removal or destruction of tissue in the expected area of ​​the surgical site. Such tools can use contact structures (such as abrasives, drills, ultrasonic horns) or non-contact structures (such as lasers) to achieve such operations. Therefore, in addition to tools using rotary motion, tools using oscillating motion, ultrasonic vibration, laser energy, electrical energy, electromagnetic energy, magnetic energy, radio frequency energy, radioactive energy, chemical energy or reactants, mechanical energy, mechanical force and thermal energy can be used, and the operating parts, operating members, tools and components in the entire surgical system are modified or replaced accordingly. Electricity can be provided by conventional electrical means and / or pneumatic means. Therefore, the description and description of the electric, mechanical, and rotating operating parts in the following examples are not intended to limit the scope of the present invention.

[0055] Regardless of the type of tool and operating portion selected, the body 22 and tissue operating portion 30 are configured together to define an operating direction of the operating member 34 relative to the surgical site S. For an operating member located at a distal end (e.g., member 34), the operating direction can be a direction toward the distal end (a direction along or parallel to the central axis 36) and / or can be a direction other than the distal direction (a direction at an angle to the central axis 36, a direction extending laterally from the central axis 36 (e.g., radially), etc.), depending on the tool, the surgical procedure or its portion or step, the surgeon's preference, etc. Figure 3-6B As shown, the operative direction is the distal direction along axis 36. Thus, when tissue manipulation member 34 is powered and aligned along the operative direction, tissue manipulation member 34 can move along the operative direction to manipulate (ie, contact and mechanically remove) desired tissue disposed along the operative direction.

[0056] The tool 20 and / or its overall control system may include at least one projection device with an emission port attached to the body 22 to assist in properly positioning the tool 20 so as to contact the intended tissue (and only the intended tissue) within the surgical site. The one or more projection devices and their multiple emission ports that can be used with the tools disclosed herein can have a variety of designs to provide different functions and benefits to the surgeon. In the most basic arrangement, the projection device of the tool used herein can project a beam of light from an emission port to form an optical positioning marker, which is essentially a "dot" or "spot" that lights up at the point where the beam of light falls on the surgical site.

[0057] Figure 1-32 shows an arrangement in which the tool 20 includes a projection device having an emission port 38 configured on the operating portion 30 so as to project an optical positioning mark 40 onto the surgical site S along the positioning direction, the optical positioning mark 40 being formed by a light beam 42 from the main body 22. In essence, the point where the light beam 42 emitted from the emission port 38 irradiates the surgical site S is the optical positioning mark 40 (at Figure 3 40) so that the tool alignment relative to the expected contact point 46 can be determined and adjusted. Figure 3 As shown, the exit port 38 may (only) include an exit optical device (lens, aperture, slit, pinhole, mask, filter, etc.) of a projection device for projecting a light beam. However, in some embodiments, the exit port 38 may also include an entrance lens / optical receiver of an imaging system (e.g., an imaging device (e.g., a camera with a CCD)) to project the light beam on a screen (e.g., Figure 5 As an alternative, the exit port 38 may include an exit port for projecting an optical positioning marker, and a second lens (not shown) may be provided as an entrance lens / optical receiver for acquiring the image. However, in situations where onboard imaging is desired, certain advantages are provided that the dual-purpose ports, lenses, or equivalents are overlapping or adjacent structures capable of emitting optical positioning markers and collecting light for the imaging device.

[0058] Figure 1-2B Also shown are optional multiple alignment marks 54 that can be placed on the tool 20 to provide the surgeon with a visual indication of the tool's orientation. The multiple marks 54 can have various shapes, such as one or more dots, lines, rings, etc., and the multiple marks 54 can be distributed along any and all sides of the operating portion 30 of the tool 20. The multiple marks 54 can be visually observable (directly or through an onboard or separate camera), and / or the multiple marks 54 can be observable through alternative imaging devices (e.g., X-ray imaging, MRI, radio frequency-generated acoustic imaging, photoacoustic imaging, ultrasound imaging, etc.). Such marks can be used with any of the embodiments disclosed herein.

[0059] Figure 4A A schematic view of an example of an optical system that can be used with tool 20, the optical system generating at least a light beam for projecting at least one optical positioning mark, Figure 4B Certain components of the optical unit within the optical system are shown.

[0060] like Figure 4AAs shown, the tool 20 includes an emission port 38, which is functionally arranged to project light onto the surgical site S and / or detect an image of the surgical site S in a direction associated with the orientation of the operating member 34. In an optical unit 60 in communication with the emission port 38, light can be generated and / or received. Figure 4A As shown, the optical unit 60 is spaced apart from the tool 20 and connected by a communication cable 26c, which may include a waveguide (e.g., one or more optical fibers) and / or one or more power or data cables. Such multiple optical fibers and multiple cables may be combined into a single conduit. However, part or all of the optical unit 60 may be located on or within the tool 20.

[0061] The cable 26c may also include multiple separate parts (e.g., one part from the outlet port 38 to the optical connector in the tool 20, and another part extending from the optical connector in the tool 20 to the optical unit 60). Such multiple detachable parts may be useful, for example, the operating part 30 with the outlet port 38 mounted thereon may be detachable from the rest of the tool 20.

[0062] like Figure 4B As shown, the optical unit 60 is attached to and in communication with the optical cable 26c and the output cable 51 to transmit the imaging signal to the display device 50. It should be understood that at least the transmission between the optical unit 60 and the display 50 may also be wireless.

[0063] At least one projection device 62 is provided in the optical unit 60, and at least one projection device 62 may include multiple laser diodes or multiple LEDs with multiple beam shaping lenses, and multiple laser diodes or multiple LEDs are most suitable for high-intensity beam projection, preferably emitting multiple parallel beams. In combination with diffractive lenses, masks, filters, slits and apertures, multiple laser diodes and multiple LEDs are further suitable for patterned beam projection and multiple matrix displays / AMOLEDs. A reflecting device (as described below, which may be a beam splitter 64) may be provided to redirect the light from the projection device 62 toward the exit port 38 into a waveguide (e.g., an optical fiber) (e.g., in the cable 26c) for emission onto the surgical site. Other focusing and guiding devices may be used, including devices that are not reflected by a beam splitter. In combination with lenses and apertures, multiple projection devices are capable of projecting multiple radially shaped beams with a focus in a fixed direction to further assist in optical distance determination, and project indicators or multiple lines.

[0064] like Figure 4A and Figure 4BAs shown, one or more projection devices 62 can use multiple optical fibers and multiple waveguides so that the optical unit 60 with the projection device 62 is spaced apart from the tool 20. However, as mentioned above, some laser diodes and LEDs and the required lenses are small enough, so if necessary, these laser diodes and LEDs can be mounted on the operating part 30 and / or the main body 22. Therefore, at least the light source / projection device 62 in the optical system can be located on the tool, on a main power supply near the tool, or even separate from the tool. The projection device 62 can be a laser, a diode, an incandescent bulb, a neon lamp, a matrix display or any other light source or device. In order to shape the beam as required, the shaping of the emitted light can be achieved by using the apertures and lenses located at the element 38, or the apertures and lenses including the element 38, which is located at the distal end exit of the waveguide. Therefore, the positions of the multiple emission ports 38 of the multiple projection devices 62 shown in the figure only represent the emission points of the light source, and the light to be emitted in the one or more configurations described above is from such a device 38 "upstream".

[0065] When optical fibers are used, the optical system can include not only a projection device, but also an imaging device. In this case, an imaging device 66 (e.g., a camera) having, for example, an imaging CCD 68 can be included in the optical system, for example, in the optical unit 60. The use of such an imaging device 66 allows the display of an observed image on the screen 50, for example, the observed image is obtained by an optical receiver or lens on the tool 20, which can be an emission port 38 co-located at the end of the projection device, or can be another lens on the tool 20 (not shown).

[0066] like Figure 4BAs shown, the device 66 is arranged so that light entering the optical unit 60 through the optical cable 26c passes through the beam splitter 64, then through the optional safety filter 70 and possibly other optical waveguides or devices before being irradiated to the CCD 68. The light beam 42 that forms the optical positioning mark emitted from the emission port 38 originates from the projection device 62 and is emitted as a beam 42a within the optical unit 60. The light beam 42a is then coupled into the optical fiber of the cable 26c by a conventional beam coupler (not shown) to project the light beam 42 from the emission port 38 at the far end of the optical fiber cable 26c. Light entering the optical receiver (e.g., the emission port 38 or another port or lens on the tool 20) is coupled into the cable 26c and transmitted as a beam 72 within the optical unit 60 to the CCD 68 of the optical device 66. By using optical fiber and bidirectional transmission, common components can be used in the optical system to simultaneously perform projection and imaging / observation, although separate paths for projection and imaging / observation are also feasible. The optics, CCD and associated control equipment can be configured and programmed to simultaneously provide real-time imaging and capture video or still photographs for storage in computer memory within the system or in removable storage media located remotely.

[0067] Figure 5 A first person view from the tool's perspective on a screen 50 is shown. From this perspective, the projected one or more optical positioning markers 40 provide support to the surgeon in determining the distance and alignment of the tool. In addition, the use of a screen 50 allows for the display of multiple "augmented reality" virtual markers (52a, 52b, 52c) on the screen, which in addition to displaying the projected positioning markers (42) also assist the surgeon in determining distance and alignment. If active distance measurement is provided, each virtual marker will indicate a different distance from the surgical site at the expected contact point 46, so that as the displayed end of the operating member 34 reaches each virtual marker in turn as the tool approaches, the surgeon obtains a real-time indication of the distance from the contact portion 46. For example, by electro-optical distance measurement, virtual marker distance information can be obtained, in which case accurate dynamic information values ​​can be determined and displayed, and if desired, the numerical values ​​can be displayed next to multiple markers. Alternatively, in a passive system, multiple markers are displayed at a fixed distance from the tool head and provide a more approximate distance indication (similar to some displays on conventional automotive rearview cameras). Whether on an active or passive basis, the distance information used to draw the multiple virtual markers on the screen 50 can be pre-derived from the field of view of the imaging device, thereby providing indicators to guide the surgeon's eyes to help determine relative distances.

[0068] As shown, the projection device's exit port 38 is located on the body so that the light originally generated by the projection device 62 is emitted along a positioning direction that is operationally associated with the operating direction. For example, the projection device can project a light beam 42, and when the light beam 42 is incident on the surgical site S, an optical positioning mark 40 is generated (marked with a circle in the figure for clarity, but it can be one or more points, lines, characters, geometric shapes, or any desired visible mark). Since the position of the exit port 38 on the tool is fixed, the position of the optical positioning mark 40 has a certain predetermined relationship with the orientation and / or position of the operating member 34 of the tool 20. By understanding the predetermined relationship, the surgeon thereby obtains information related to the position and orientation of the operating member relative to the surgical site S.

[0069] For example, if desired, the light beam 42 can extend distally and parallel to the central axis 36 and maintain a predetermined known distance 44 (e.g., 1 cm) from the central axis 36. Thus, if the tool 20 is moved in an operating direction 48 parallel to the central axis (see Figure 6B ) is moved to contact the surgical site at point 46, the optical positioning mark 40 will be located at a distance 44 from the position 46, and the central axis 36 will contact the surgical site S at the position 46 (the center of which is marked with an X in the figure for clarity). In other words, the light beam 42 produces a visually discernible optical positioning mark 40 at a known distance 44 from the central contact point of the operating member 34 on the surgical site S, and if the operating member 34 is moved axially, the operating member 34 will act on the surgical site. When the surgeon moves the tool in a direction closer to the surgical site in the patient's body, the optical positioning mark 40 remains visible and provides information to the surgeon so that the tool can be properly and reliably operated to reach and contact the intended target tissue at point 46.

[0070] The distance 44 (e.g., 1 cm, but other values ​​are also suitable) is predetermined and communicated to the surgeon during training. Thus, a skilled surgeon will understand that the tool 20 with the optical positioning marker 40 located at a distance 44 (1 cm) above the expected contact position 46 is first positioned on the surgical site S (see FIG. Fig. 6A ), and then, while maintaining the position of the optical positioning mark, by moving the optical positioning mark in the operating direction 48 toward the desired contact position (distal and axial, see Figure 6B) Move the tool 20 so that the center of the operating member 34 will contact the desired contact location 46 (in this example, along the central axis 36). The distance 44 can be selected by the arrangement and configuration of the operating member 34, the ejection port 38, the operating portion 30, etc. By using a sufficient offset, a light beam 42 is generated that is parallel to the central axis 36 but sufficiently spaced from other parts of the tool 20 to prevent the light beam from being obscured or blocked, and the optical positioning marker 40 can be made visible at the distance 44 near the target site 46.

[0071] Therefore, by direct visual observation, the optical positioning mark 40 can be noticed. However, the mark and the surrounding parts can also be captured by an imaging device such as a camera, an endoscope, etc. (independent of the tool 20 or carried with the tool 20) and displayed on a display device (such as an electronic screen). Therefore, the optical positioning mark 40 provides information related to at least one of the position and orientation of the operating member 34 in the surgical site and / or information related to at least one of the position and orientation of the operating direction in the surgical site.

[0072] In the non-limiting example above, the tool 20 uses a distal operating direction 48 (along the central axis 36) and a parallel light beam 42 (see Fig. 6A and Figure 6B ). However, the operating direction 48 of the contact need not necessarily be distal or parallel to the central axis 36. If so, the exit port 38 of the projection device can be constructed and aimed accordingly so as to project the light beam 42 in a complementary direction to produce the optical positioning mark 40 at the desired location. For example, if the operating direction 48 is perpendicular to the central axis 36 (extending radially outward from the central axis 36), the light beam 42 can extend radially outward from the central axis and be aligned with the central axis, or can extend in a direction parallel to the line (which extends radially outward from the central axis and is aligned with the central axis) (see Figure 13A-Figure 16 ). Other angles and orientations besides distal or radial / perpendicular are possible, depending on factors such as the tool, the type of operative portion involved, the surgical procedure, surgeon preference, etc.

[0073] Furthermore, the light beam 42 does not necessarily have to be projected parallel to the operating direction 48 or the central axis 36 . Fig. 7A and Figure 7B An alternative aiming of the projection device's exit port 38 and light beam 42 is shown. Here, the light beam 42 is angled downward (as shown) and passes below the central axis 36. In this orientation, the position of the optical positioning marker 40 on the surgical site S changes as the tool 20 moves along the operating direction 48. Thus, Fig. 7A The distance 44 is greater than Figure 7B The distance 44 at the time of contact with the expected position 46 is shown in the figure. Figure 7BThe optical positioning mark 40 in the embodiment is slightly above the position 46 when in contact, and the construction of the tool 20 and the projection device's emission port 38 can make the mark above, below, beside, or coincident with the target position 46 (if shading is avoided). Figure 7B The operating direction 48 in FIG. 4 is shown as being parallel to the central axis 36 , however, this is not required and may instead be parallel to the beam 42 or aligned with neither, depending on factors such as tool type and configuration, surgical procedure, surgical preference, etc.

[0074] Furthermore, the emitted light beam does not have to be a single light beam, does not have to be projected as only one point, and does not have to use only parallel light beams to project an optical positioning mark having a static size. Fig. 8A and Figure 8B An alternative one or more optical positioning marks are shown, which include an outer (circular) portion 40a formed by a beam 42a and a central (point) portion 40b formed by a beam 42b. The beam 42a is conical, and the beam 42b is linear as the above beam 42. Beam shaping can be achieved by using multiple masks, multiple apertures, multiple filters, or multiple lenses at one or more exit ports 38. Since the beam 42a is conical, for example, when the operating member 34 is moved to contact the operating member 34 with the expected position 46 ( Figure 8B ), the outer portion 40a has a first size ( Fig. 8A ), and has a (smaller) second size at a smaller second distance. The center portion 40b is optional, and as shown, the center portion 40b can be spaced apart from the contact position 46 at a distance 44. Fig. 6A and 6B The use of a non-parallel, non-axial beam allows the size of the optical positioning marker 40a to change as the tool moves toward or away from the surgical site, and the observed size provides the surgeon with information about the distance to the surgical site. As described above, it is also feasible to arrange the optical positioning marker 40a to be non-parallel to the central axis 36 and / or the operating direction 48, depending on the above factors.

[0075] It should be understood that in embodiments where multiple beams are projected (whether from a single exit port or from multiple exit ports), the different beams may be composed of light of different wavelengths, which can also provide information to the surgeon. Such beams can be generated in different ways, for example, by coupling two colors of light or a broad spectrum of light into an optical fiber or waveguide and then separating the individual colors using wavelength sensitive filters or beam splitters, or by using light polarization and polarization filtering. Such color differentiation can be applied to all embodiments disclosed herein that use multiple beams.

[0076] Figure 9-11B An alternative design is shown in which multiple beams are emitted from multiple exit ports dispersed circumferentially around the tool. Fig. 9 and Fig.10 As shown, four exit ports 38a, 38b, 38c, 38d emit multiple light beams 42a, 42b, 42c, 42d to form multiple optical positioning marks 40a, 40b, 40c, 40d. The light from all exit ports can be generated by a single light source, such as in the optical unit described above, which is located on the tool or remotely operated. Alternatively, multiple light sources can be provided, each of which provides light to one or more exit ports. If so, multiple conventional light guides can be used as needed to split the generated light into different optical fibers leading to each exit port.

[0077] Although the multiple beams may be directed in other relative orientations as described above, Fig. 9 The device shown generates a plurality of light beams extending parallel to the central axis 36 and the operating direction 48 (eg, Fig. 11B Each beam is projected to a plurality of equal distances 44a, 44b, 44c, 44d away from the intended contact point 46 (see Fig.10 ), however these distances are not necessarily equal. Fig.11A and Fig. 11B The plurality of parallel light beams 42 a - 42 d are shown forming a plurality of markings 40 a - 40 d that remain equally spaced from the contact point 46 as the tool moves in an operating direction 48 parallel to the central axis 36 .

[0078] Despite Figure 9-11B Four such beams are shown spaced 90 degrees apart, but it will be appreciated that two or more beams may be used arranged around point 46, equidistant or unequally spaced and / or circumferentially, as desired.

[0079] Fig. 11C Shows the Figure 9-11B A slight variation of the device shown in FIG. 4 is made in which one or more of the four optical positioning marks 40a-40d can be in a shape other than a dot or a line. As shown in the figure, Fig. 11CThe multiple markings in include indicators to provide the surgeon with information about the orientation of the tool 20 relative to the target 46 (X). Mark 40d is the letter R (for right), mark 40b is the letter L (for left), and marks 40a and 40c are arrows (for up and down, respectively). When the tool is oriented (by the surgeon or the robot) so that mark 40a (upward arrow) points upward, the use of such indicators on one or more marks can provide additional feedback that can help directly operate the tool or robotically operate the tool through a user interface (for example, using similar indicators on one or more input devices thereof). Any symbols, indicators, designs, etc. can be created to allow one or more optical positioning marks to provide additional information to the surgeon. This information may be more important in cases where the operating portion is asymmetrical relative to the tool, or where the orientation of the tool within the surgical site or during a particular surgical step is critical.

[0080] Fig.11D Another variation is shown in which four optical positioning markers 40a-40d together form two lines of intersection at the target site 46. Each of the plurality of emission ports 38a-38d is configured to emit light beams 42a-42d in a widened line, all of which can intersect and overlap at the target site 46 along the axis 36. It is feasible to form such an intersection using only two such emission ports separated by 90 degrees, but the emission ports must be arranged so that the operating member 34 does not cause occlusion. As the tool 20 moves closer to the target site 46, the intersection formed by the plurality of optical positioning markers 40a-40d becomes smaller, thereby providing alignment and distance feedback to the surgeon.

[0081] Fig. 12A and Fig. 12B Another variation is shown in which multiple exit ports emit multiple non-parallel beams that cross across the target area. As shown, two exit ports 38a, 38b are disposed on opposite sides of the central axis 36. Two beams 42a, 42b are emitted and cross just in front of the operating member 34. When the tool is in Fig.11A When the tool is in the position shown, the two optical positioning markers 40a, 40b are spaced a distance 44 from the contact point 46. As the tool moves in the operating direction 48, the two optical positioning markers 40a, 40b converge on the point 46, thereby assisting the surgeon in alignment and providing information about the distance to the target as the distance 44 decreases. It should be understood that more than two such emission ports may be used, and the emission ports may be arranged uniformly or non-uniformly, at different angles or spacings on one or more paths around the central axis 36 as desired.

[0082] Fig.13A and Fig. 13BAn alternative design is shown, wherein one or more exit ports include multiple optical devices, lenses, etc., and the exit port can emit a light beam that is split into at least two parts so that at least two parts extend from the exit port in different directions. At least in some applications, the splitting of the light beam can be more efficient spatially and commercially than providing an exit port for each light beam. As shown, two exit ports 38a, 38b emit four light beams 42a1, 42a2, 42b1, 42b2 to produce four optical positioning markers 40a1, 40a2, 40b1, 40b2. Two light beams 42a1 and 42b1 extend forward parallel to the central axis 36, and two light beams 42a2 and 42b2 extend perpendicular to the central axis 36 (aligned with each other). When operating the tool during surgery, the four light beams and four markers can assist the surgeon in identifying some parts of the surgical cavity other than the target area. There can be one or more beam splitters, each of which can split the light into two or more beams. The multiple beams can also be aimed in different directions, such as parallel, non-parallel, perpendicular, skewed, etc. The light from each exit port can be generated by a single light source, such as in the optical unit described above, which is located on the tool or remotely operated. Alternatively, multiple light sources can be provided, each providing light to one or more exit ports. If so, multiple conventional light guides can be used as needed to split the generated light into different optical fibers leading to each exit port. Therefore, the use of beam splitting provides further options for the generation and direction of multiple optical positioning marks.

[0083] Fig.14A and Fig. 14B An alternative design of the operating portion 130 of the tool 120 is shown. The operating portion 130 includes a shield 131 to prevent contact with some parts of the surgical site, but also allows contact with other parts of the surgical site when the tool is moved and used. Depending on the surgical procedure, this shield can have different arrangements and orientations. As shown, the shield 131 covers the bottom side 134a and distal end 134b of the operating member 134 of the operating portion 130.

[0084] The presence of the shield 131 allows at least one ejection port to be placed in the shield 131 to project optical positioning marks from the ejection port. As shown, two ejection ports 138a, 138b are located at or adjacent to the distal end 131a of the shield, and two ejection ports 138c, 138d are located in the proximal region 131b. The four ejection ports are located around the operating member 134 in the transverse direction and emit four light beams 142a, 142b, 142c, 142d to produce four optical positioning marks 140a, 140b, 140c, 140d. The multiple light beams extend parallel to the operating direction 148 (towards the contact point 146 of the central target area), where the multiple light beams and the operating direction are perpendicular to the central axis 136.

[0085] The surgical site and multiple optical localization markers can be directly visualized ( Fig.15 ) or visualized on a separately provided display screen 150 ( Fig.16 , by using multiple optical receivers on the tool 120, the multiple optical receivers are within or separated from the multiple emission ports). Therefore, if necessary, one or more optical receivers 158a, 158b can be set on the tool 120 to image the surgical site and multiple optical positioning markers 140a-140d. As shown, the optical receiver 158a is located at the distal end 131a of the protective cover, and another optical receiver 158b is adjacent to the proximal end 131c adjacent to the protective cover portion 130. Each optical receiver can provide its own perspective, or computer processing can be used to combine multiple perspectives provided by multiple optical receivers to generate a single perspective in two dimensions or three dimensions. As shown, two receivers 158a, 158b are provided that are axially located at the top of the tool 120 and point in the direction of operation, but if necessary, the two or more receivers can be distributed in different ways and can point outward in more directions to provide up to 360 degrees of viewing angle of the entire wound cavity.

[0086] For example, multiple optical receivers can be connected to an optical unit (such as unit 60 mentioned above) having one or more CCDs via multiple optical fibers and multiple waveguides. If so, by triangulating the location of a given point in the surgical site using two optical receivers with known positions on the tool (e.g., by identifying the CCD pixels affected by objects observed from the two locations), the distance to the given point can be determined. Thus, using two optical receivers 158a, 158b, the distance to the expected contact point 146 or one of the multiple optical positioning markers 140a-140d can be determined. The distance information can be provided to the surgeon in different ways, such as through a screen readout, through augmented reality on a screen (such as screen 150), etc.

[0087] Fig.17A schematic diagram showing the components of the tools described herein and their interconnection with other components within a surgical system. As mentioned above, the tools described herein can be of various types, and thus the system for controlling the tools can be varied accordingly in a conventional manner understood by those skilled in the art.

[0088] As shown in the figure and as mentioned above, tool 20 can be connected with multiple cables 26a-26c and multiple conduits 28a, 28b.For example, multiple cables can be connected with these elements (it can include or contain multiple characteristics of optical unit 60, as mentioned above) of such as power module 27a, control module 27b and optical communication module 27c in system 200.Multiple conduits can be connected with surgical fluid source 29a and suction device 29b, and suction device 29b is used to remove any material from the fluid in the patient's body and removed from the patient during the operation.Each in multiple modules and fluid source / remover is controlled by one or more controllers 202 (one is shown) in system 200 for function and / or provides power. As schematically shown for simplicity, the controller 202 may include or be connected to a central processing unit 204, a memory 206, programming data and other stored data 208, and at least one input-output device 210, which is used to activate and control the features and functions of the tool 20, and is also used to activate and control multiple modules 27a-27c, fluid source 29a, remover 29b and display 50.

[0089] It should be understood that several separate controllers are actually provided to control different parts of the tool and the entire surgical system. One or more controllers do not have to be located at the same location as the tool, and one or more controllers may be at least partially remote (on-site) or remote (off-site), connected via conventional wired or wireless connections. The input-output device 210 may include a plurality of operable input devices, such as buttons, triggers, switches, keyboards, keypads, touch screens, microphones, etc., which are located on the tool itself and on other devices within the system for controlling various elements of the system. For output, a plurality of items such as screens, lights, indicators, speakers, etc. can be provided to provide feedback to the user regarding the status of the tool and its various components or the surgical procedure. One or more conventional power sources (not shown) may be provided to Fig.17 Power the tool, controller and all other components shown.

[0090] Figure 18-21An alternative embodiment of a surgical device 220 is shown, which can be attached to a surgical tool 222, which can be used to manipulate the desired tissue in a surgical site S in a patient's body. The surgical tool has a body 224 and a tissue manipulation member 226 located on the body, and the tissue manipulation member 226 is used to manipulate the tissue in some way. As shown, the surgical tool 222 is an electric surgical tool, and the manipulation member 226 is a conventional mechanical rotating grinder that destroys the tissue by direct contact when rotating. It should be understood that in addition to mechanical and / or rotating members, other types of manipulation members can also be used in the tool 222. Therefore, as used herein, "manipulation" can be any type of change, cutting, removal or destruction of tissue in the desired area of ​​the surgical site. Such a tool can use a contact structure (e.g., a grinder, a drill, an ultrasonic horn) or a non-contact structure (e.g., a laser) to achieve such manipulation. Therefore, in addition to tools that employ rotational motion, tools that employ oscillatory motion, ultrasonic vibrations, laser energy, electrical energy, electromagnetic energy, magnetic energy, mechanical force, radiofrequency energy, radioactive energy, chemical energy or reactants, mechanical energy, and thermal energy may be utilized, and the operating portions, operating members, tools, and components of the entire surgical system may be modified or replaced accordingly. Electricity may be provided by conventional electrical means and / or pneumatic means. Therefore, the illustration and description of the electrical, mechanical, and rotational operating portions in the following examples are not intended to limit the scope of the invention. In addition, as discussed in more detail below, reference is made to Figure 22-26 , surgical tools do not have to be powered, so the tissue manipulation portion can be a tissue manipulation portion of a passive surgical or dental tool, such as a scalpel, an auger, tweezers, scissors, retractors, elevators, forceps, clamps, scrapers, files, etc.

[0091] like Figure 18-21 As schematically shown in , the housing 234 of the device 220 is distally attached to the tool 222 near the end 228, in this case, by double-sided tape 254. Fig.18 In the example shown, the tissue manipulation member 226 is configured to operate along an operating direction 230, which is generally transverse relative to the central axis 232 of the tool 222, and the central axis 232 extends along the portion of the tool containing the tissue manipulation member. It should be understood that other linear, curved or angled shapes, or tools and / or tissue manipulation members, whether regular or irregular, are feasible. In addition, the tissue manipulation member is not necessarily located at the distal end of the tool, and more than one tissue manipulation member or a tissue manipulation member configured with a tool to provide more than one exposed portion can be used.

[0092] Regardless of whether a powered or non-powered tool is selected and the type of tissue manipulation member, the body 224 and the tissue manipulation member 226 are configured together with the surgical device 220 (i.e., complementary in shape) so that when the surgical device is attached to the tool 222, certain characteristics and functions of the surgical device are expectedly related to the operating direction 230 of the tissue manipulation member 226 relative to the surgical site S.

[0093] Thus, as shown, the surgical device 220 may include, for example, a housing 234 configured to be removably attached to the body 224 of the tool along the surgical alignment direction relative to the body. The surgical device 220 may include at least one projection device having an emission port 236, which is located on the housing 234. The emission port 236 emits a light beam 238, which is used to emit an optical positioning marker 240 onto the surgical site S. The power for generating the light beam 238 may be provided by a battery (not shown) within the housing 234, or by a cable 246 extending from the housing to a power source or other controller. The cable 246 may be, for example, a flat ribbon cable with double-sided tape 256 or equivalent to secure the cable 246 to the body 224 of the tool. Because the surgical device 220 is configured and attached to the tool 222 in a complementary and cooperative manner, the light beam 238 extends in one direction, thereby providing information about the operating direction 230 to the user.

[0094] As shown, the light beam 238 extends parallel to the operating direction 230 and maintains a predetermined distance 242 from the longitudinal centerline 244 of the tissue manipulation member 226. Therefore, the optical positioning marker 240 will be located at a distance 242 from the expected contact point 244 of the tissue manipulation member 226.

[0095] It should be understood that one or more projection devices and one or more exit ports can have different configurations and positions depending on the application scenario. One or more such devices can be lasers, diodes, bulbs, neon lights, matrix displays or any other light source or device, and laser diodes or LEDs with multiple beam shaping lenses can be used. Laser diodes or LEDs are best suited for high-intensity beam projection. The beam can be a "dot", line, image, character, etc. In combination with diffractive lenses, masks, filters, slits and apertures, multiple laser diodes and multiple LEDs are further suitable for patterned beam projection and multiple matrix displays / AMOLEDs. Green, red or other laser beams (within 0.5 mm or less, depending on the tool and lighting requirements) can be used to provide point positioning marks. A reflecting device (such as a conventional beam splitter) can be provided to redirect the light from the generating device toward the exit port 236 into a waveguide (such as an optical fiber) (for example, in the cable 246) to be emitted to the surgical site. Other focusing and guiding devices can be used, including devices that are not reflected by a beam splitter. In combination with lenses and apertures, one or more projection devices can project multiple radially shaped light beams with focal points in a fixed direction to further assist in optical distance determination, as well as project indicators or multiple lines. Therefore, the location of the emission port 236 on the projection device only represents the emission point of the light source, and the light to be emitted is located upstream of such port or elsewhere in the housing 234.

[0096] It should also be understood that the optical positioning mark created does not have to be formed by laser light in a directly visible wavelength. For example, light can be emitted in the UV or IR range, which is not directly visible to the naked eye, but can be detected by an appropriately selected camera, CCD or another sensor. Such an optical positioning mark can become visible on a display device that can be viewed by the surgeon, although it is not visible when directly observing the surgical site. Therefore, the term optical positioning mark in this article means a mark that can be visible to the surgeon, whether directly visible or indirectly visible through a display device, whether at a wavelength visible to the naked eye or a wavelength that is not visible.

[0097] In addition, it should be understood that visible or invisible markers can be used together. Multiple visible markers with one or more colors based on some kind of LED can be created, but invisible (e.g., generated by IR laser) markers can still be created. If so, it is necessary to set up an exit port for visible laser and another exit port for invisible laser on the surgical device. As described above, one or two types of lasers (light, laser; visible, invisible) can be generated by multiple elements located on the surgical tool 220 and / or remotely, and delivered to the exit port by using a control / power cable 246 such as an optical fiber.

[0098] It should be understood that, depending on the type of tool, the operating direction 230 may be a radial or distal direction relative to the central axis 232, and / or may be a direction other than a radial or distal direction (i.e., at a non-perpendicular angle to the central axis 232). In any case, when the surgical device 220 is properly attached and powered, the tool 222 can be moved along the operating direction to operate (i.e., contact and remove) the desired tissue arranged along the operating direction using one or more optical positioning markers 240 and / or one or more light beams 238 as a guide.

[0099] The surgical tool 220 may also include an imaging device for imaging the surgical site S to achieve indirect visualization, such as displaying it on a display screen (to be discussed below). Figure 18-21 As shown, the housing 234 may include at least one optical receiver 248, which may be of various types and have various configurations. If desired, the optical receiver 248 may be a camera mounted in the housing 234. Alternatively, the optical receiver 248 may be an entrance lens of an optical system that communicates with a remote imaging device (e.g., via a cable 246). If multiple optical receivers are provided, each optical receiver may provide its own perspective, or, using computer processing, multiple perspectives provided by multiple optical receivers may be combined to generate a single perspective in two dimensions or three dimensions. As shown, one receiver 248 is located near the emission port 236 and points in the direction of operation.

[0100] The optical receiver may be connected to an optical unit having one or more remote CCDs as described above, for example, via a plurality of optical fibers and a plurality of waveguides within cable 246. Alternatively, if the optical receiver includes a camera located on housing 234, its electronic output signal may be transmitted along cable 246 to a remote control and processing device for further transmission to a display.

[0101] For use in a surgical environment, in some embodiments, the camera can have a field of view of at least 90 degrees, a focal range of 3 mm to 50 mm, a pixel resolution of, for example, 200x200 to 640x640, and a frame rate of 30fps, although these exemplary parameters are not limiting and other available camera parameters may be suitable.

[0102] The surgical device may also include an illumination device 252 for illuminating the surgical site. As shown, a white LED attached to the housing 234 may be used to provide such illumination. Other light sources may also be provided on the housing or remotely. The use of the illumination device 252 may be useful, for example, if an imaging device is used within a cavity of the subject. If direct optical visualization or visible light visualization on a display is to be performed, the illumination device 252 should be complementary to the other elements and should not make one or more optical positioning markers 240 and / or their light beams 238 difficult to discern or invisible.

[0103] As shown, the projection device's exit port 236 is located on the housing 234 so that the generated light is emitted along a positioning direction that is operably associated with the operating direction. Due to the position of the exit port 236 on the housing 234 and its cooperative attachment to the tool 222, the position of the optical positioning marker 240 has a predetermined relationship with the orientation and / or position of the tissue manipulation member 226 of the tool 220. By understanding the predetermined relationship, the surgeon thereby obtains information related to the position and orientation of the manipulation member relative to the surgical site S. For example, if desired, the light beam 238 can extend distally parallel to the positioning direction and the contact point 244 and maintain a preset known distance 242 (e.g., 1 cm) therefrom. Therefore, if the tool 222 moves along the operating direction 230 and contacts the surgical site at point 244, the optical positioning marker 240 will be located at a distance 242 from the position 244, and the center of the tissue manipulation member 226 will contact the surgical site S at the position 244 (for clarity, the center of the position is marked with an X in the figure). In other words, the light beam 238 produces a visually discernible optical positioning mark 240 at a known distance 242 from the point on the surgical site S that contacts the center of the operating member 226 that will act on the surgical site. As the surgeon moves the tool closer to the surgical site within the patient's body, the optical positioning mark 240 remains visible and provides information to the surgeon so that the tool can be properly and reliably operated to reach and contact the intended target tissue at point 244.

[0104] The distance 242 (e.g., 1 cm, but other values ​​are also suitable) is predetermined by the configuration of the interacting components of the surgical tool 222 and the surgical device 220, and the distance 242 is communicated to the surgeon during training. Thus, a skilled surgeon will understand that by first positioning the tool 222 with the optical positioning marker 240 at a distance 242 (1 cm) above the intended contact location 244 on the surgical site S, and then by moving the tool 222 in the operating direction toward the intended contact location while maintaining the position of the optical positioning marker, the center of the tissue manipulation member 224 will contact the intended contact location 244. By the arrangement and construction of the various components described above, the distance 242 can be selected. By using a sufficient offset to generate the light beam 238, it is slightly (at the distal end) separated from other parts of the tool 222, thereby preventing the light beam from being obscured or blocked, and making the optical positioning marker 240 visible at the distance 242 near the target site 244. However, in addition to a single beam parallel to line 230, other beam arrangements or orientations, beam combinations, or beam arrangements or orientations, beam combinations as described above may be used.

[0105] Figure 22-25 A surgical device 320 is depicted that can be attached to a non-electric surgical tool 322 (e.g., a vascular clamp). The surgical device 320 may include a housing 334 and a cable 346 similar to those described above, and the device 320 may include some or all of the features of the devices mentioned above. Thus, for example, the housing may include multiple elements, each of which includes, for example, one or more of a plurality of indicator devices 326a, 326b, a plurality of imaging devices 348, and a plurality of lighting devices 352. The plurality of indicator devices may include a visible device (e.g., an LED) 326a and a visible or invisible laser device 326b. Multiple imaging devices 348 (not shown) may be added for stereoscopic viewing. One or more lighting devices 352 may use LEDs to illuminate the surgical site.

[0106] The housing 324 and the cable 346 can be attached to the tool 322 by adhesives, tapes, etc. as described above. Alternatively, or in addition, a connection structure 321 can be provided on the housing 324 for attaching the device 320 to the tool 322 or the auxiliary device 320 to the tool 322. As shown, the connection structure 321 includes two L-shaped brackets of a size suitable for connecting to a jaw 323 of the vascular clamp 322. Other structures can be adopted, whether it is a custom size for the tool as shown, or a size adjustable and attachable. Therefore, the connection structure can adopt mechanical / geometric fixing elements, such as brackets, clamps, rings, springs, doors, pivoting covers, snaps, flanges, grooves, dowel pins, sockets, scaffolds, etc. These structures can be flexible or relatively more rigid. These structures can be designed to match the profile of a specific tool, or modular, and adjustable, to be used with tools of different configurations.

[0107] A magnetic connection may alternatively or additionally be employed, for example by attaching a magnet to a housing of the device, which housing may be attached to a magnetic portion of the tool or the housing may be attached to a magnet attached to the tool.

[0108] Fig.26 A slightly modified device 420 is shown, in this example, the device 420 is attached to a tool 422 by a separate attachment element 421, here shown as a band around the device 420 on the tool 422. One or more attachment elements 421 can be used alone, or in combination with mechanical, geometric, magnetic or adhesive attachment as described above. As described above, the device includes a housing 434 and a cable 446 and some or all of the other components mentioned above located on the housing 334, which will not be described in detail here.

[0109] As shown, the attachment element 421 is a cuff in the form of a preformed sleeve made of a shrink film polymer (e.g., PVC, polyolefin, etc.). The size of the sleeve provided to the surgeon with the device and / or tool can be larger than the size of the tool and device. Once the device is in place, the sleeve is placed around the tool and device, and then heated to shrink the film, thereby fixing the position of the device.

[0110] The attachment element 421 need not necessarily be in the form of a sleeve, but may also be a strip of film that shrinks after being put into place. In addition, stretch film, plastic film, adhesive film or other films may be used. Strips or tubular materials with hook-and-loop fasteners, "self-locking straps" or other clamping connections may also be used together with sutures or other lacing connectors. Thus, each individual attachment element may be used with or in place of the element 421 shown in the figure. Fig.26 One or more of these possible attachment elements may also be used with devices 220 , 320 .

[0111] Figure 18-26 The device in can be battery powered or wirelessly connected to other parts of the surgical system, thereby eliminating the need for cables 346 / 446 and simplifying the form factor and connection structure.

[0112] In use, surgical tools having positioning and / or guiding properties, such as those described above, may be beneficial in surgeries described as "delicate" because the tissue to be operated on is in close proximity to tissue such as nerves, blood vessels, etc. that must not be disturbed or damaged. In addition, such devices may be beneficial in surgeries where the tissue to be operated on is difficult to reach and / or cannot be directly viewed, such as spinal surgery, which requires access from the back but the surgical procedure is performed ventrally.

[0113] During surgery, use e.g. Fig.14A When using a tool such as that shown in Figure 14B, the surgeon first turns it on and performs a functional / diagnostic check of the tool and connection system to ensure that everything is in working order and connected correctly. Figure 18-26 The device in the wound will first be attached to the intended tool in one or more intended ways. The operating components (if any) and the multiple projection devices will then be turned off. The tool is first inserted into the wound cavity shield to prevent the working end from getting stuck or undesired tissue damage, for example in the case of a tool with a grinder head. During the approach phase, the operating components of the tool as well as the multiple projection devices can be turned off, and only one or more cameras will be turned on from the beginning. After the tool is inserted into the wound, one or more projection devices can be turned on to produce one or more optical positioning marks to ensure that multiple light beams do not accidentally shine into the eyes of someone in the surgical team. Then, by feel and observation of the screen (such as in Fig.14A / 14B- Fig.15 , or if being used, by direct visual observation), guide the tool to the approximate intended contact area within the surgical site.

[0114] Approaching the surgical site and tissue to be avoided is guided primarily by one or more cameras of the tool and by using multiple positioning markers and any distance information provided on the screen, so that it is known how far or close the tool and the operating members of the tool are to the target surgical site and various areas to be avoided.

[0115] When the surgical site is reached and viewed from the tool's perspective, the tool, in particular the operating member facing the surgical site, is precisely aligned. Precise alignment can be checked by utilizing any distance information provided on the screen using electro-optical distance measurement and information about multiple distances within the wound cavity that can be obtained. When multiple positioning markers are used, the multiple positioning markers outline the contour / edge of the area of ​​the working surface, and this contour is consistent with the area of ​​the planned surgery while avoiding any sensitive areas, at which time the working surface (operating member) of the tool will be opened.

[0116] The tool with the opening operating member is then carefully moved toward the surgical site to ensure that the correct alignment is not lost during the approach process, and the main part of the surgical procedure, such as tissue removal, is started. During this movement, alignment information feedback is provided to the surgeon through multiple optical positioning marks, multiple marks on the tool, so that the desired alignment is maintained through contact. After a brief contact, the tool can be moved back to observe the progress of the surgical procedure, and if necessary, the tool can be realigned to further contact the target area or adjacent target areas and then moved into contact. As needed, this alignment and contact can be repeated multiple times until the end of the surgical procedure, for example when the purpose of the tissue operation is achieved and the purpose of the tissue operation is confirmed by observation and / or electro-optical distance measurement, and certain landmarks in the wound and / or multiple optical positioning marks and / or decisions made based on the information / images provided can be referenced.

[0117] In the final stage of the surgical procedure, the tool is withdrawn from the surgical site and the operating member is closed, which is essentially the reverse of the steps of the first approach / insertion stage. During the extraction process, as during the insertion process, it is of utmost importance for the surgeon to avoid contact with sensitive tissue and unnecessary damage to the tissue.

[0118] If the tool is not a power tool, such as a clamp, then the use of such a tool or other related tools in the surgery will of course be modified accordingly depending on the various parameters of the tool and the intended surgery.

[0119] The surgical procedure can be used with image-guided surgical methods, for example, using positioning information and alignment information provided by third-person information (e.g., X-ray, ultrasound, CT, MRI, positron emission tomography) of the image-guided system, which can supplement information from positioning and imaging, especially information from the first-person perspective. This information can be displayed on a split screen or multiple screens in addition to images from the tool, images from an endoscope viewing the tool, or combined with a virtual display, virtual reality imagery, and / or augmented reality imagery. In addition, as an option, the surgeon can select and switch between different views to be displayed, depending on the preferred viewpoint at each stage of the surgical procedure.

[0120] Surgical procedures using the tools disclosed above can also be performed by a robot managed / controlled by a surgeon who can select images / viewpoints before and during surgery based on preference. Other support devices that help improve the precision and quality of the surgical procedure, such as an N-type positioner, can also be employed.

[0121] Thus, the disclosed subject matter provides an easy-to-use and user-friendly device and system for assisting surgical procedures by providing at least one optical positioning marker projected from a surgical tool, by providing visualization, by providing positioning, etc. The present disclosure is applicable to many different surgical tools and surgical procedures, and the multiple optical positioning markers can have a variety of forms. Thus, the disclosed concepts are not intended to be limited to application to any particular tool or surgical procedure, or to any number or orientation of one or more optical positioning markers, multiple visualized surgical areas, etc.

[0122] Although the preferred embodiments of the present invention have been fully described above, it should be understood that any and all equivalent implementations of the present invention are included within the scope and spirit of the present invention. Therefore, the described embodiments are presented only by way of example and are not intended to limit the present invention. Therefore, although specific embodiments of the present invention have been described and shown, it will be understood by those of ordinary skill in the art that since many modifications can be made, the present invention is not limited thereto, and elements of some embodiments can be combined with elements of other embodiments to create new embodiments, all of which are still in accordance with the present disclosure. Therefore, it is conceivable that any and all such embodiments are included in the present invention, as these embodiments may fall within the literal or equivalent scope of the appended claims.

Claims

1. A surgical device attached to a body of a surgical tool, the surgical tool being useful for manipulating a desired tissue in a surgical site within a patient's body, the surgical device comprising: a housing configured to be removably attached to the body in a surgical alignment direction relative to the body; an illumination device, the illumination device being disposed on the housing and used for illuminating the surgical site; as well as At least one imaging device is used to obtain an image of the surgical site illuminated by the lighting device, and the at least one imaging device includes an optical receiver attached to the housing and used to obtain the image of the surgical site.

2. The surgical device according to claim 1, wherein: The at least one imaging device comprises a camera for receiving the image from the optical receiver.

3. The surgical device according to claim 1 or 2, wherein: The at least one imaging device uses a plurality of the optical receivers, and the plurality of images acquired by the plurality of the optical receivers are complementary to each other.

4. The surgical device according to any one of claims 1 to 3, wherein: Also included is a display device for providing a display of the image acquired by the at least one imaging device.

5. The surgical device according to claim 4, wherein: The display includes a virtual positioning marker overlaid on the image of the surgical site to provide information regarding at least one of a position, orientation, and distance of the surgical tool relative to the surgical site.

6. The surgical device according to claim 4, wherein: The display device is spaced apart from the housing and the body and is located outside the patient's body for easy viewing by a user of the tool.

7. The surgical device according to any one of claims 1 to 6, wherein: The lighting device comprises at least one LED.

8. The surgical device according to any one of claims 1 to 7, wherein: The shell is connected to a power source, and the power source is used to supply power to a plurality of components attached to the shell.

9. The surgical device according to any one of claims 1 to 8, wherein: The shell can be fixed to the outer surface of the body at least mechanically, chemically or magnetically.

10. The surgical device according to any one of claims 1 to 9, wherein: It also includes a projection device, which has an emission port, and the emission port is located on the shell. When the shell is located on the main body along the surgical alignment direction, the projection device can be powered to emit an optical positioning mark from the emission port along the positioning direction onto the surgical site. The optical positioning mark provides information related to at least one of the position and orientation of the main body of the surgical tool within the surgical site. The at least one imaging device is capable of imaging the optical positioning mark.

11. The surgical device according to claim 10, wherein: The projection device includes at least one LED and a laser to generate one or more of the optical positioning marks.

12. A surgical device attached to a body of a surgical tool, the surgical tool being useful for manipulating desired tissue in a surgical site within a patient's body, the surgical device comprising: a housing configured to be detachably attached to the body in a surgical alignment direction relative to the body; at least one imaging device, the at least one imaging device being used to acquire an image of the surgical site, the at least one imaging device comprising an optical receiver, the optical receiver being attached to the housing and being used to acquire the image of the surgical site, the at least one imaging device comprising a camera, the camera being used to receive the image from the optical receiver; as well as A display device for providing a display of the image acquired by the at least one imaging device, the display including virtual positioning markers overlaid on the image of the surgical site to provide information related to at least one of the position, orientation and distance of the surgical tool relative to the surgical site.

13. The surgical device according to claim 12, wherein: The at least one imaging device uses a plurality of the optical receivers, and the plurality of images acquired by the plurality of the optical receivers are complementary to each other.

14. The surgical device according to claim 12 or 13, wherein: Also included is a lighting device, which is disposed on the housing and is used to illuminate the surgical site.

15. The surgical device according to any one of claims 12 to 14, wherein: The shell is connected to a power source, and the power source is used to supply power to a plurality of components attached to the shell.

16. The surgical device according to any one of claims 12 to 15, wherein: The housing may be fixed to the body at least mechanically, geometrically, chemically or magnetically.

17. The surgical device according to any one of claims 12 to 16, wherein: It also includes a projection device, which has an emission port, and the emission port is located on the shell. When the shell is located on the main body along the surgical alignment direction, the optical positioning mark is emitted from the emission port along the positioning direction to the surgical site. The optical positioning mark can be detected by the imaging device and can be displayed on the display of the image.

18. The surgical device according to claim 17, wherein: The projection device includes at least one LED and a laser to generate one or more of the optical positioning marks.

19. The surgical device according to any one of claims 12 to 18, wherein: The display device is spaced apart from the shell and the main body and is located outside the patient's body to facilitate observation by a user of the tool.

20. The surgical device according to any one of claims 12 to 19, wherein: The lighting device comprises at least one LED.

21. A surgical device attached to a body of a surgical tool for manipulating desired tissue in a surgical site within a patient's body, the surgical device comprising: a housing configured to be removably attached to the body in a surgical alignment direction relative to the body; as well as A projection device having an emission port, wherein the emission port is located on the shell, and when the shell is located on the main body along the surgical alignment direction, the projection device can be powered to emit an optical positioning mark from the emission port along the positioning direction onto the surgical site, wherein the optical positioning mark provides information related to at least one of the position and orientation of the main body of the surgical tool within the surgical site.

22. The surgical device according to claim 21, wherein: The housing may be fixed to the body at least mechanically, geometrically, chemically or magnetically.

23. The surgical device according to claim 21 or 22, wherein: The housing is connected to a power source, and the power source is used to supply power to the projection device.

24. The surgical device according to any one of claims 21 to 23, wherein: The device also includes a lighting device, which is disposed on the housing and used to illuminate the surgical site. The lighting device includes at least one LED, and the at least one LED is disposed on the housing at a position adjacent to the ejection port.

25. The surgical device according to claim 24, wherein: The lighting device and the projection device are connected to a power source.

26. The surgical device according to any one of claims 21 to 25, wherein: It also includes at least one imaging device, which is used to obtain the image of the surgical site. The at least one imaging device includes an optical receiver and a camera. The optical receiver is attached to the shell and is used to obtain the image of the surgical site. The camera is used to receive the image from the optical receiver.

27. The surgical device according to any one of claims 21 to 26, wherein: The projection device comprises an electric light source, and the emission port comprises a lens, wherein the lens is used to guide the light from the electric light source to a positioning direction in the form of a light beam to form the optical positioning mark.

28. The surgical device according to any one of claims 21 to 27, wherein: The projection device comprises a laser, and the emission port comprises a lens, wherein the lens is used to guide the laser light from the laser to a positioning direction to form the optical positioning mark.

29. The surgical device according to claim 28, wherein: The laser emits visible laser light.

30. The surgical device according to claim 28, wherein: The laser emits infrared laser, and the surgical device further comprises: at least one imaging device, the at least one imaging device being used to acquire an image of the surgical site, the at least one imaging device comprising an optical receiver and a camera, the optical receiver being attached to the housing and being used to acquire the image of the surgical site including the optical positioning marker, the camera being used to receive the image from the optical receiver; and A display device is used to provide a display of the image acquired by the at least one imaging device including the optical positioning mark.

31. A kit comprising a surgical device and a surgical tool according to any one of the preceding claims.

Images